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Qatomah A, Aihara H. Colorectal endoscopic submucosal dissection in the USA: The current state and future perspectives. DEN OPEN 2025; 5:e394. [PMID: 38915785 PMCID: PMC11194299 DOI: 10.1002/deo2.394] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 04/30/2024] [Revised: 05/16/2024] [Accepted: 05/27/2024] [Indexed: 06/26/2024]
Abstract
Endoscopic submucosal dissection (ESD) is a transformative advancement in the endoscopic management of superficial gastrointestinal lesions. Initially conceived for the treatment of early gastric cancer, ESD has demonstrated proficiency in achieving en-bloc resection of superficial gastrointestinal lesions. ESD has experienced widespread acceptance in Japan and East Asia; however, its adoption in the USA remains delayed. This initial hesitancy could be attributed to procedural complexity and training demands; nonetheless, recently, ESD has been gaining popularity in the USA. This is due to the advancements in endoscopic technology, tailored training programs, and cumulative evidence regarding the efficacy and safety of ESDs. This review aimed to deliberate the historical progress, current implementation, and prospective trajectory of ESDs in the USA. With ongoing clinical research, technological integration, and educational efforts, ESD is likely to become the gold standard for managing large gastrointesitinal lesions. This progress marks an imperative step toward less invasive, more precise, and patient-centric approaches regarding advanced therapeutic endoscopy in the USA.
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Affiliation(s)
- Abdulrahman Qatomah
- Division of Gastroenterology and HepatologyMcGill University Health CenterMontrealCanada
- Division of Gastroenterology and HepatologyKing Faisal Specialist Hospital and Research CenterJeddahSaudi Arabia
| | - Hiroyuki Aihara
- Division of Gastroenterology, Hepatology and EndoscopyBrigham and Women's Hospital, Harvard Medical SchoolBostonMassachusettsUSA
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Higuchi K, Goto O, Matsuda A, Nakagome S, Habu T, Ishikawa Y, Koizumi E, Kirita K, Noda H, Onda T, Akimoto T, Omori J, Akimoto N, Yoshida H, Iwakiri K. Potential of Direct Oral Anticoagulant in Bleeding After Gastric Endoscopic Submucosal Dissection: A Systematic Review and Meta-Analysis. Dig Dis Sci 2024; 69:940-948. [PMID: 38252209 DOI: 10.1007/s10620-024-08271-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/07/2023] [Accepted: 01/02/2024] [Indexed: 01/23/2024]
Abstract
BACKGROUND AND AIMS An increasing number of patients are undergoing gastric endoscopic submucosal dissection (ESD) with active prescriptions of direct oral anticoagulants (DOACs). Only a few reports have described the effects of DOAC intake on postoperative bleeding. We aimed to investigate the bleeding risk associated with DOACs after gastric ESD. METHODS Clinical studies published up to April 2022 showing bleeding rates after gastric ESD in patients taking DOACs were identified using electronic searches. The primary outcome was the rate of bleeding after gastric ESD in patients receiving DOACs compared to those not receiving antithrombotic therapy. In this meta-analysis, odds ratios (ORs) were calculated and pooled using a random effects model. The secondary outcome was the difference in the bleeding rate between patients treated with DOACs and those treated with warfarin and antiplatelet drugs. RESULTS Seven studies were included in this meta-analysis. The pooled analysis showed that DOACs had a higher bleeding rate than non-thrombotic therapy (17.0% vs. 3.4%; OR 5.72; 95% confidence interval [CI], 4.33-7.54; I2 = 0%). The bleeding risk associated with DOAC administration was similar to that associated with warfarin (17.0% vs. 20.0%; OR 0.83; 95% CI 0.59-1.18; I2 = 0%), whereas it was higher than that associated with antiplatelet administration (16.9% vs. 11.0%; OR 1.63; 95% CI 1.14-2.34; I2 = 8%). CONCLUSIONS This meta-analysis reveals that the bleeding risk of DOACs is higher than that of non-antithrombotics and antiplatelets, whereas it is comparable to that of warfarin. Gastric ESD in patients on anticoagulants requires careful postoperative management.
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Affiliation(s)
- Kazutoshi Higuchi
- Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan.
| | - Osamu Goto
- Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
- Endoscopy Center, Nippon Medical School Hospital, Tokyo, Japan
| | - Akihisa Matsuda
- Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan
| | - Shun Nakagome
- Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
| | - Tsugumi Habu
- Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
| | - Yumiko Ishikawa
- Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
| | - Eriko Koizumi
- Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
| | - Kumiko Kirita
- Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
| | - Hiroto Noda
- Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
| | - Takeshi Onda
- Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
| | - Teppei Akimoto
- Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
| | - Jun Omori
- Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
| | - Naohiko Akimoto
- Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
| | - Hiroshi Yoshida
- Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Nippon Medical School, Graduate School of Medicine, Tokyo, Japan
| | - Katsuhiko Iwakiri
- Department of Gastroenterology, Nippon Medical School, Graduate School of Medicine, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
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Cheema HI, Tharian B, Inamdar S, Garcia-Saenz-de-Sicilia M, Cengiz C. Recent advances in endoscopic management of gastric neoplasms. World J Gastrointest Endosc 2023; 15:319-337. [PMID: 37274561 PMCID: PMC10236974 DOI: 10.4253/wjge.v15.i5.319] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/20/2022] [Revised: 01/12/2023] [Accepted: 04/06/2023] [Indexed: 05/16/2023] Open
Abstract
The development and clinical application of new diagnostic endoscopic technologies such as endoscopic ultrasonography with biopsy, magnification endoscopy, and narrow-band imaging, more recently supplemented by artificial intelligence, have enabled wider recognition and detection of various gastric neoplasms including early gastric cancer (EGC) and subepithelial tumors, such as gastrointestinal stromal tumors and neuroendocrine tumors. Over the last decade, the evolution of novel advanced therapeutic endoscopic techniques, such as endoscopic mucosal resection, endoscopic submucosal dissection, endoscopic full-thickness resection, and submucosal tunneling endoscopic resection, along with the advent of a broad array of endoscopic accessories, has provided a promising and yet less invasive strategy for treating gastric neoplasms with the advantage of a reduced need for gastric surgery. Thus, the management algorithms of various gastric tumors in a defined subset of the patient population at low risk of lymph node metastasis and amenable to endoscopic resection, may require revision considering upcoming data given the high success rate of en bloc resection by experienced endoscopists. Moreover, endoscopic surveillance protocols for precancerous gastric lesions will continue to be refined by systematic reviews and meta-analyses of further research. However, the lack of familiarity with subtle endoscopic changes associated with EGC, as well as longer procedural time, evolving resection techniques and tools, a steep learning curve of such high-risk procedures, and lack of coding are issues that do not appeal to many gastroenterologists in the field. This review summarizes recent advances in the endoscopic management of gastric neoplasms, with special emphasis on diagnostic and therapeutic methods and their future prospects.
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Affiliation(s)
- Hira Imad Cheema
- Department of Internal Medicine, Baptist Health Medical Center, Little Rock, AR 72205, United States
| | - Benjamin Tharian
- Department of Interventional Endoscopy/Gastroenterology, Bayfront Health, Digestive Health Institute, St. Petersberg, FL 33701, United States
| | - Sumant Inamdar
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, University of Arkansas for Medical Sciences, Little Rock, AR 72205, United States
| | - Mauricio Garcia-Saenz-de-Sicilia
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, University of Arkansas for Medical Sciences, Little Rock, AR 72205, United States
| | - Cem Cengiz
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, University of Arkansas for Medical Sciences, Little Rock, AR 72205, United States
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, John L. McClellan Memorial Veterans Hospital, Little Rock, AR 72205, United States
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, TOBB University of Economics and Technology, Ankara 06510, Turkey
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Li M, Jin X, Zhou X, Lou G, Ji F, Wang L, Jin H, Huang X, Zhao J, Bao H, Huang L, Shi C, Jin B, Lu H, Lyu B. Effectiveness and safety of a newly designed self-assembling gel in the treatment of endoscopic submucosal dissection-induced gastric ulcer: A multicenter randomized controlled trial. Front Pharmacol 2022; 13:1002381. [DOI: 10.3389/fphar.2022.1002381] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/25/2022] [Accepted: 11/18/2022] [Indexed: 12/03/2022] Open
Abstract
Objectives: To evaluate the effectiveness and safety of a newly designed self-assembling gel in treating ESD-induced gastric ulcers in patients.Methods: This open-label, multicenter, randomized controlled trial enrolled patients who underwent ESD between September 2020 and May 2021. Patients were randomized (1:1) to receive the gel (applied to cover the entire ulcer bed under endoscopic guidance immediately after ESD; gel group) or not (control group). The primary outcome was the ulcer healing rate at 28 days. And the secondary outcomes were the delayed bleeding, changes in the ulcer stage, and adverse events.Results: Finally, 125 patients (mean age, 63.7 years; 70 [56.0%] males) were enrolled. The ulcer healing rate was higher in the gel group than in the control group at 28 days (96.9 ± 4.1% vs. 94.7 ± 5.0%; p = 0.001). The ulcer reduction rate at 28 days differed significantly (p < 0.001) between ulcers with majority gel coverage (99.8%), ulcers with minority gel coverage (96.2%), and ulcers with no gel coverage (98.0%). Delayed bleeding was found in 1/63 gel-treated patients (1.6%) versus 5/62 controls (8.1%). A1-stage ulcers were found in 16/63 patients in the gel group versus 44/62 patients in the control group (25.4% vs. 71.0%, p < 0.001) at 3–5 days.Conclusion: The newly developed self-assembling gel was safe and effective in accelerating gastric ulcer healing in patients after ESD.Clinical Trial Registration: UMIN Clinical Trials Registry System (registration number, ChiCTR2100052935).
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Horie Y, Horiuchi Y, Ishiyama A, Tsuchida T, Yoshimizu S, Hirasawa T, Fujisaki J, Maetani I, Yoshio T. The effect of antithrombotic drug use on delayed bleeding with esophageal endoscopic resection. J Gastroenterol Hepatol 2022; 37:1792-1800. [PMID: 35844140 DOI: 10.1111/jgh.15944] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/17/2022] [Revised: 07/02/2022] [Accepted: 07/11/2022] [Indexed: 12/09/2022]
Abstract
BACKGROUND AND AIM Whether antithrombotic drugs increase the risk of post-esophageal endoscopic resection bleeding is unknown. This study examined the effect of antithrombotic drugs, aspirin, thienopyridine, direct oral anticoagulants (DOAC), and warfarin, on post-esophageal endoscopic resection bleeding. METHODS We enrolled 957 patients (1202 esophageal tumors) treated with endoscopic resection and classified them based on antithrombotic drug use as no use, aspirin, thienopyridine, DOAC, and warfarin. Patients using antiplatelet drugs (i.e. aspirin and thienopyridine) were further sub-classified based on their continued or discontinued use before endoscopic resection. The bleeding rates were compared between these groups to assess the effects of antithrombotic drug use and interruption of antiplatelet therapy on post-esophageal endoscopic resection bleeding. RESULTS The post-endoscopic resection bleeding rate was 0.3% (95% CI, 0.1-1) in the group without antithrombotic drug use, 4.5% (95% CI, 0.1-23) in the aspirin-continued group, 2.9% (95% CI, 0.1-15) in the aspirin-discontinued group, 0% (95% CI, 0-78) in the replaced thienopyridine with aspirin group, 0% (95% CI, 0-26) in the thienopyridine-discontinued group, 13% (95% CI, 1.6-38) in the DOAC group, and 0% (95% CI, 0-45) in the warfarin group. The post-endoscopic resection bleeding rate in the DOAC group was significantly higher than that in the group without antithrombotic drugs (P = 0.003). The post-endoscopic resection bleeding rates did not differ between the other groups. CONCLUSIONS Our results suggest that discontinuing aspirin is not necessary for esophageal endoscopic resection while we must be careful regarding DOAC.
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Affiliation(s)
- Yoshimasa Horie
- Department of Gastroenterology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.,Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Ohashi Medical Center, Tokyo, Japan
| | - Yusuke Horiuchi
- Department of Gastroenterology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
| | - Akiyoshi Ishiyama
- Department of Gastroenterology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
| | - Tomohiro Tsuchida
- Department of Gastroenterology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
| | - Shoichi Yoshimizu
- Department of Gastroenterology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
| | - Toshiaki Hirasawa
- Department of Gastroenterology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
| | - Junko Fujisaki
- Department of Gastroenterology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
| | - Iruru Maetani
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Ohashi Medical Center, Tokyo, Japan
| | - Toshiyuki Yoshio
- Department of Gastroenterology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan
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Funasaka K, Yamada H, Horiguchi N, Osaki H, Yoshida D, Terada T, Koyama K, Okubo M, Tahara T, Nagasaka M, Nakagawa Y, Shibata T, Ohmiya N. Complete omission of second-look endoscopy after gastric endoscopic submucosal dissection in real-world practice. Medicine (Baltimore) 2022; 101:e29386. [PMID: 35839022 PMCID: PMC11132336 DOI: 10.1097/md.0000000000029386] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/17/2021] [Accepted: 04/08/2022] [Indexed: 11/25/2022] Open
Abstract
Gastric endoscopic submucosal dissection (ESD) is increasingly performed in patients receiving antithrombotic therapy. Second-look endoscopy (SLE) has been performed empirically in several clinical settings. We investigated whether SLE omission was associated with an increased risk of postESD bleeding in all patients, including those administered antithrombotic agents. Between July 2016 and June 2018, 229 patients were treated with a clinical pathway for gastric ESD that involved SLE on the day after ESD (SLE group). Between September 2018 and May 2020, 215 patients were treated using a clinical pathway that did not include SLE (nonSLE group). We retrospectively compared the incidence of postESD bleeding among the propensity score-matched cohorts and determined the risk factors for postESD bleeding using multivariate analysis. The propensity score-matched cohorts showed no significant differences in the incidence of postESD bleeding between the SLE (3.2%) and nonSLE (5.1%) groups. Multivariate analysis revealed that the presence of lesions in the lower gastric body (adjusted odds ratio [OR] 2.17, 95% confidence interval [CI] 1.06-4.35, P.03) was a significant risk factor for postESD bleeding during admission, whereas resected specimen size ≥ 40 mm (adjusted OR 3.21, 95% CI 1.19-8.19, P.02) and antiplatelet therapy (adjusted OR 4.16, 95% CI 1.47-11.80, P.007) were significant risk factors after discharge. Complete omission of SLE after gastric ESD does not increase postESD bleeding in clinical practice.
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Affiliation(s)
- Kohei Funasaka
- Department of Gastroenterology, Fujita Health University School of Medicine, Toyoake, Japan
| | - Hyuga Yamada
- Department of Gastroenterology, Fujita Health University School of Medicine, Toyoake, Japan
| | - Noriyuki Horiguchi
- Department of Gastroenterology, Fujita Health University School of Medicine, Toyoake, Japan
| | - Hayato Osaki
- Department of Gastroenterology, Fujita Health University School of Medicine, Toyoake, Japan
| | - Dai Yoshida
- Department of Gastroenterology, Fujita Health University School of Medicine, Toyoake, Japan
| | - Tsuyoshi Terada
- Department of Gastroenterology, Fujita Health University School of Medicine, Toyoake, Japan
| | - Keishi Koyama
- Department of Gastroenterology, Fujita Health University School of Medicine, Toyoake, Japan
| | - Masaaki Okubo
- Department of Gastroenterology, Fujita Health University School of Medicine, Toyoake, Japan
| | - Tomomitsu Tahara
- Department of Gastroenterology, Kansai Medical University School of Medicine, Osaka, Japan
| | - Mitsuo Nagasaka
- Department of Gastroenterology, Fujita Health University School of Medicine, Toyoake, Japan
| | - Yoshihito Nakagawa
- Department of Gastroenterology, Fujita Health University School of Medicine, Toyoake, Japan
| | - Tomoyuki Shibata
- Department of Gastroenterology, Fujita Health University School of Medicine, Toyoake, Japan
| | - Naoki Ohmiya
- Department of Gastroenterology, Fujita Health University School of Medicine, Toyoake, Japan
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Chen Y, Zhao X, Wang D, Liu X, Chen J, Song J, Bai T, Hou X. Endoscopic Delivery of Polymers Reduces Delayed Bleeding after Gastric Endoscopic Submucosal Dissection: A Systematic Review and Meta-Analysis. Polymers (Basel) 2022; 14:2387. [PMID: 35745963 PMCID: PMC9227627 DOI: 10.3390/polym14122387] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/11/2022] [Revised: 05/20/2022] [Accepted: 06/09/2022] [Indexed: 01/27/2023] Open
Abstract
New endoscopic approaches for the prevention of delayed bleeding (DB) after gastric endoscopic submucosal dissection (ESD) have been reported in recent years, and endoscopic delivery of biodegradable polymers for iatrogenic ulcer hemostasis and coverage has emerged as one of the most promising techniques for post-ESD management. However, the comparative efficacy of these techniques remains uncertain. We performed a systematic search of multiple databases up to May 2022 to identify studies reporting DB rates as outcomes in patients undergoing gastric ESD who were treated with subsequent endoscopic management, including endoscopic closure (clip-based methods and suturing), PGA sheet tissue shielding, and hemostatic powder/gel spray (including polymeric sealants and other adhesives). The risk ratios (RRs) of delayed bleeding in treatment groups and control groups were pooled, and the Bayesian framework was used to perform a network meta-analysis (NMA). Among these studies, 16 head-to-head comparisons that covered 2742 lesions were included in the NMA. Tissue shielding using PGA sheets significantly reduced the risk of DB by nearly two thirds in high-risk patients, while hemostatic spray systems, primarily polymer-based, reduced DB in low-risk patients nine-fold. Researchers should recognize the essential role of polymers in the management of ESD-induced ulcers, and develop and validate clinical application strategies for promising materials.
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Affiliation(s)
- Youli Chen
- Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China; (Y.C.); (D.W.); (X.L.); (J.C.); (X.H.)
| | - Xinyan Zhao
- Department of Spleen and Stomach Disease, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan 430006, China;
| | - Dongke Wang
- Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China; (Y.C.); (D.W.); (X.L.); (J.C.); (X.H.)
| | - Xinghuang Liu
- Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China; (Y.C.); (D.W.); (X.L.); (J.C.); (X.H.)
| | - Jie Chen
- Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China; (Y.C.); (D.W.); (X.L.); (J.C.); (X.H.)
| | - Jun Song
- Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China; (Y.C.); (D.W.); (X.L.); (J.C.); (X.H.)
| | - Tao Bai
- Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China; (Y.C.); (D.W.); (X.L.); (J.C.); (X.H.)
| | - Xiaohua Hou
- Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China; (Y.C.); (D.W.); (X.L.); (J.C.); (X.H.)
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Hidaka Y, Imai T, Inaba T, Kagawa T, Omae K, Tanaka S. Efficacy of vonoprazan against bleeding from endoscopic submucosal dissection-induced gastric ulcers under antithrombotic medication: A cross-design synthesis of randomized and observational studies. PLoS One 2021; 16:e0261703. [PMID: 34941937 PMCID: PMC8699580 DOI: 10.1371/journal.pone.0261703] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/12/2021] [Accepted: 12/09/2021] [Indexed: 12/15/2022] Open
Abstract
Vonoprazan, a potassium-competitive acid blocker, is expected to be superior to proton pump inhibitors (PPIs) in preventing post-endoscopic submucosal dissection (ESD)-induced gastric bleeding. However, the results of randomized controlled trials (RCTs) and observational studies on the efficacy of vonoprazan have been inconsistent. This study aimed to evaluate the effectiveness of vonoprazan in antithrombotic drug users, a population that has been excluded from RCTs. Treatment effects were assessed using cross-design synthesis, which can be adjusted for differences in study design and patient characteristics. We used data from an RCT in Japan (70 patients in the vonoprazan group and 69 in the PPI group) and an observational study (408 patients in the vonoprazan group and 870 in the PPI group). After matching, among the antithrombotic drug users in the observational study, post-ESD bleeding was noted in 8 out of 86 patients in the vonoprazan group and 18 out of 86 patients in the PPI group. After pooling the data from the RCT and observational study, the risk difference for antithrombotic drug users was -14.6% (95% CI: -22.0 to -7.2). CDS analysis suggested that vonoprazan is more effective than PPIs in preventing post-ESD bleeding among patients administered antithrombotic medications.
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Affiliation(s)
- Yu Hidaka
- Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan
- * E-mail:
| | - Toru Imai
- Department of Clinical Biostatistics, Kyoto University Graduate School of Medicine, Kyoto, Japan
| | - Tomoki Inaba
- Department of Gastroenterology, Kagawa Prefectural Central Hospital, Takamatsu, Kagawa, Japan
| | - Tomo Kagawa
- Department of Gastroenterology, Kagawa Prefectural Central Hospital, Takamatsu, Kagawa, Japan
| | - Katsuhiro Omae
- Department of Data Science, National Cerebral and Cardiovascular Center, Suita, Osaka, Japan
| | - Shiro Tanaka
- Department of Clinical Biostatistics, Kyoto University Graduate School of Medicine, Kyoto, Japan
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Li M, Jin H, Shi C, Lyu B, Ying X, Shi Y. A Novel Self-Assembled Gel for Gastric Endoscopic Submucosal Dissection-Induced Ulcer: A Preclinical Study in a Porcine Model. Front Pharmacol 2021; 12:700387. [PMID: 34658850 PMCID: PMC8517079 DOI: 10.3389/fphar.2021.700387] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/28/2021] [Accepted: 09/20/2021] [Indexed: 01/15/2023] Open
Abstract
Endoscopic submucosal dissection (ESD) is a routine procedure for the management of early gastrointestinal neoplasia, but it results in large ulcers. This study aims to examine the feasibility and effectiveness of a newly developed self-assembled gel on the ulcer healing process after ESD. Sixteen 2.0-cm (diameter) gastric ulcers were created by ESD in five pigs. All ulcers were randomized: control group (n = 7, routine ulcer management) and gel-treated group (n = 9). The gel was applied to cover the whole ulcer bed through the endoscope immediately after ESD. The feasibility of this endoscopic treatment modality was macroscopically accessed by endoscopy. The effectiveness was evaluated based on the ulcer area and histology changes at 14 days after ESD. The gel-treated group showed higher healing activity compared with the control ulcers on day 14 after ESD. The percentage of healing was higher for the gel-treated ulcers than in control ones (96.2 ± 2.2% vs. 91.9 ± 4.5%, p = 0.035). The extent of the new epithelium covering the ulcer was greater in the gel group than in controls. One delayed overt bleeding occurred in the control group (14.3%). This novel gel might promote the speed of ulcer healing after ESD, leading to higher epithelium formation.
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Affiliation(s)
| | | | | | - Bin Lyu
- Department of Gastroenterology, First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China
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Jung DH, Moon HS, Park CH, Park JC. Polysaccharide hemostatic powder to prevent bleeding after endoscopic submucosal dissection in high risk patients: a randomized controlled trial. Endoscopy 2021; 53:994-1002. [PMID: 33200808 DOI: 10.1055/a-1312-9420] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
Abstract
BACKGROUND : Bleeding after endoscopic submucosal dissection (ESD) is a severe adverse event. Several methods to prevent post-ESD bleeding (PEB) have been introduced; however, they have not been widely used because of technical difficulties. We aimed to investigate whether polysaccharide hemostatic powder (PHP), which is very easy to apply, can prevent early post-ESD bleeding, especially in patients with a high risk of post-ESD bleeding. METHODS : This was a prospective, multicenter, randomized, open-label, controlled trial. Patients with a high risk for post-ESD bleeding were enrolled. Patients with gastric neoplasms in whom the resected specimen size was expected to be > 40 mm and those who were regularly taking antithrombotic agents were defined as high risk patients. Patients were randomly assigned to the PHP or control groups. RESULTS: Between May 2017 and September 2018, 143 patients were enrolled (PHP group, 73; control group, 70). The total post-ESD bleeding rate was 6.3 % (PHP group, 5.5 % vs. control group, 7.1 %; P = 0.74). There was no bleeding within 7 days after ESD in the PHP group. Continued antithrombotic use was an independent risk factor for post-ESD bleeding. In subgroup analysis excluding the patients who continued to take antithrombotic agents (n = 129) during ESD, the rate of post-ESD bleeding tended to be lower in the PHP group than in the control group (0 % vs. 6.3 %; P = 0.06). CONCLUSION : PHP did not demonstrate a significant effect on the prevention of post-ESD bleeding in this study. Further larger scale, randomized controlled trials are needed to confirm this.
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Affiliation(s)
- Da Hyun Jung
- Department of Gastroenterology, Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Hee Seok Moon
- Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University College of Medicine, Daejeon, Republic of Korea
| | - Chan Hyuk Park
- Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Seoul, Republic of Korea
| | - Jun Chul Park
- Department of Gastroenterology, Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
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11
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Jung DH, Park JC. Strategies that Reduce Post-endoscopic Submucosal Dissection Bleeding. THE KOREAN JOURNAL OF HELICOBACTER AND UPPER GASTROINTESTINAL RESEARCH 2021. [DOI: 10.7704/kjhugr.2021.0028] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/22/2022]
Abstract
Bleeding after endoscopic submucosal dissection (ESD), one of the most common postprocedural adverse events, is the main cause of increased readmission rates and hospital costs. Generally, the incidence of post-ESD bleeding is estimated to be about 5%. However, the incidence of bleeding is particularly increased in high-risk patients. In particular, it has an incidence of over 50% in patients that use antithrombotic agents. The well-known risk factors for post-ESD bleeding include antithrombotic therapy, lesions in the proximal stomach, specimen size >4 cm, and concomitant renal disease. Currently, the number of patients at a high risk of post-ESD bleeding has been increasing. This may be due to the aging society and the increase in the usage of antithrombotic agents. Therefore, several strategies have been employed to prevent post-ESD bleeding. These strategies include acid inhibition therapy, preventive hemostasis using Doppler endoscopic ultrasound and artery-selective clipping, second look endoscopy, the closings method, and the shield methods. However, these methods are technically demanding, which hinders their wide usage in clinical practice. Recently, several hemostatic powders have been developed and clinically used in the treatment of gastrointestinal bleeding. In this article, we review the risk factors for post-ESD bleeding and the recently introduced prevention methods. Moreover, we aimed to explore realistic and appropriate strategies for the prevention of post-ESD bleeding.
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12
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Uozumi T, Sumiyoshi T, Tomita Y, Tokuchi K, Sakano H, Yoshida M, Fujii R, Minagawa T, Okagawa Y, Morita K, Yane K, Ihara H, Hirayama M, Kondo H. Does second-look endoscopy reduce the bleeding after gastric endoscopic submucosal dissection for patients receiving antithrombotic therapy? BMC Cancer 2021; 21:946. [PMID: 34425774 PMCID: PMC8381513 DOI: 10.1186/s12885-021-08679-7] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/17/2020] [Accepted: 08/12/2021] [Indexed: 02/08/2023] Open
Abstract
Background In patients with average risk of bleeding, second-look endoscopy does not reportedly reduce bleeding after gastric endoscopic submucosal dissection. However, effectiveness of second-look endoscopy for patients with a high risk of bleeding, such as those who are taking antithrombotic agents, is unclear. Hence, this study aims to clarify the effectiveness of second-look endoscopy for patients with antithrombotic therapy. Methods We studied 142 consecutive patients with 173 gastric epithelial neoplasms who were routinely taking antithrombotic agents and were treated by endoscopic submucosal dissection at Tonan Hospital between November 2013 and December 2019. They were classified into two groups: those with second-look endoscopy (SLE group, 69 patients with 85 lesions) and those without second-look endoscopy (non-SLE group, 73 patients with 88 lesions). The incidence of post-endoscopic submucosal dissection bleeding was compared between the SLE and non-SLE groups. Results There were no statistical differences in the rate of patients undergoing single antiplatelet therapy, single anticoagulant therapy, and multiple therapy between the SLE and non-SLE groups (SLE group vs. non-SLE group; 32 [46.4%], 16 [23.2%], and 21 [30.4%] patients vs. 37 [50.7%], 20 [27.4%], and 16 [21.9%] patients, respectively; p = 0.50). Post-endoscopic submucosal dissection bleeding incidence was 21.7% (15/69) and 21.9% (16/73) in the SLE and non-SLE groups, respectively, and did not significantly differ between the two groups (p = 0.98). Conclusions For patients taking antithrombotic agents, the incidence of post-endoscopic submucosal dissection bleeding was not reduced by second-look endoscopy.
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Affiliation(s)
- Takeshi Uozumi
- Department of Gastroenterology, Tonan Hospital, Kita 4, Nishi 7, Chuo-ku, Sapporo, Hokkaido, 060-0004, Japan.
| | - Tetsuya Sumiyoshi
- Department of Gastroenterology, Tonan Hospital, Kita 4, Nishi 7, Chuo-ku, Sapporo, Hokkaido, 060-0004, Japan
| | - Yusuke Tomita
- Department of Gastroenterology, Tonan Hospital, Kita 4, Nishi 7, Chuo-ku, Sapporo, Hokkaido, 060-0004, Japan
| | - Kaho Tokuchi
- Department of Gastroenterology, Tonan Hospital, Kita 4, Nishi 7, Chuo-ku, Sapporo, Hokkaido, 060-0004, Japan
| | - Hiroya Sakano
- Department of Gastroenterology, Tonan Hospital, Kita 4, Nishi 7, Chuo-ku, Sapporo, Hokkaido, 060-0004, Japan
| | - Masahiro Yoshida
- Department of Gastroenterology, Tonan Hospital, Kita 4, Nishi 7, Chuo-ku, Sapporo, Hokkaido, 060-0004, Japan
| | - Ryoji Fujii
- Department of Gastroenterology, Tonan Hospital, Kita 4, Nishi 7, Chuo-ku, Sapporo, Hokkaido, 060-0004, Japan
| | - Takeyoshi Minagawa
- Department of Gastroenterology, Tonan Hospital, Kita 4, Nishi 7, Chuo-ku, Sapporo, Hokkaido, 060-0004, Japan
| | - Yutaka Okagawa
- Department of Gastroenterology, Tonan Hospital, Kita 4, Nishi 7, Chuo-ku, Sapporo, Hokkaido, 060-0004, Japan
| | - Kotaro Morita
- Department of Gastroenterology, Tonan Hospital, Kita 4, Nishi 7, Chuo-ku, Sapporo, Hokkaido, 060-0004, Japan
| | - Kei Yane
- Department of Gastroenterology, Tonan Hospital, Kita 4, Nishi 7, Chuo-ku, Sapporo, Hokkaido, 060-0004, Japan
| | - Hideyuki Ihara
- Department of Gastroenterology, Tonan Hospital, Kita 4, Nishi 7, Chuo-ku, Sapporo, Hokkaido, 060-0004, Japan
| | - Michiaki Hirayama
- Department of Gastroenterology, Tonan Hospital, Kita 4, Nishi 7, Chuo-ku, Sapporo, Hokkaido, 060-0004, Japan
| | - Hitoshi Kondo
- Department of Gastroenterology, Tonan Hospital, Kita 4, Nishi 7, Chuo-ku, Sapporo, Hokkaido, 060-0004, Japan
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13
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Ishida T, Dohi O, Yamada S, Yasuda T, Yamada N, Tomie A, Tsuji T, Horii Y, Majima A, Horie R, Fukui A, Zen K, Tomatsuri N, Yagi N, Naito Y, Itoh Y. Clinical Outcomes of Vonoprazan-Treated Patients after Endoscopic Submucosal Dissection for Gastric Neoplasms: A Prospective Multicenter Observation Study. Digestion 2021; 102:386-396. [PMID: 32585678 DOI: 10.1159/000507807] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/13/2020] [Accepted: 04/09/2020] [Indexed: 02/04/2023]
Abstract
BACKGROUND Vonoprazan (VPZ) has the potential to prevent delayed bleeding and promote ulcer healing after endoscopic submucosal dissection (ESD) similar to proton pump inhibitors (PPIs). OBJECTIVE We aimed to evaluate the outcomes of VPZ-treated patients after ESD and compared the efficacy and feasibility in preventing a delayed bleeding and in healing an artificial ulcer after ESD between the VPZ and PPI therapies. METHODS This was a prospective, observation study in 11 Japanese medical institutions. We enrolled and evaluated 223 patients who underwent gastric ESD followed by VPZ treatment (VPZ group). We selected 385 patients who underwent gastric ESD followed by PPI treatment as historical controls (PPI group) to compare the outcomes between the VPZ and PPI groups using a propensity score matching analysis. RESULTS Among the 223 patients treated with VPZ, 173 were men and 50 were women with a median age of 72 years and with a median tumor size of 12.0 mm. Rates of en bloc resection and complete resection were 99.1 and 94.2%, respectively. Lymphovascular invasion was found in 6 (6.3%) cases. Intraoperative perforation and delayed bleeding occurred in 3 (1.3%) and 10 patients (4.5%), respectively. Scarring of artificial post-ESD ulcer was found in 153 patients (68.6%) at 6 weeks after ESD. The 205 pairs of propensity score-matched patients were comparable between the VPZ and PPI groups. The rate of delayed bleeding in the VPZ and PPI groups was 3.9 and 4.4%, respectively (difference, 0.5 percentage points; 95% confidence interval, -3.7 to 2.8%; non-inferiority, p = 0.01). Therefore, VPZ therapy demonstrated non-inferiority against PPI therapy in reducing the rate of delayed bleeding. The scar-stage ulcer at 6 weeks in the VPZ group and 8 weeks in the PPI group was 68.3 and 74.6%, respectively (p = 0.19). CONCLUSIONS VPZ therapy showed an efficacy and feasibility in preventing a delayed bleeding after ESD similar to the PPI therapy. VPZ for 6 weeks and PPI for 8 weeks were similarly effective for an artificial ulcer healing after ESD.
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Affiliation(s)
- Tsugitaka Ishida
- Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan
| | - Osamu Dohi
- Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan,
| | - Shinya Yamada
- Department of Gastroenterology and Hepatology, Japanese Red Cross Society Kyoto Daiichi Hospital, Kyoto, Japan
| | - Takeshi Yasuda
- Department of Gastroenterology, Asahi University Hospital, Gifu, Japan
| | - Nobuhisa Yamada
- Department of Gastroenterology, Matsushita Memorial Hospital, Osaka, Japan
| | - Akira Tomie
- Department of Gastroenterology, Kyoto Yamashiro General Medical Center, Kyoto, Japan.,Department of Gastroenterology, Saiseikai Kyoto Hospital, Kyoto, Japan
| | - Toshifumi Tsuji
- Department of Gastroenterology, Fukuchiyama City Hospital, Kyoto, Japan
| | - Yusuke Horii
- Department of Gastroenterology, Maizuru Medical Center, Kyoto, Japan.,Department of Gastroenterology, Medical Corporation Keishinkai, Kyoto Kidugawa Hospital, Kyoto, Japan
| | - Atsushi Majima
- Department of Gastroenterology and Hepatology, Omihachiman Community Medical Center, Shiga, Japan
| | - Ryusuke Horie
- Department of Gastroenterology, JCHO Kyoto Kuramaguchi Medical Center, Kyoto, Japan
| | - Akifumi Fukui
- Department of Gastroenterology, North Medical Center Kyoto Prefectural University of Medicine, Kyoto, Japan
| | - Keika Zen
- Department of Gastroenterology, Otsu City Hospital, Shiga, Japan
| | - Naoya Tomatsuri
- Department of Gastroenterology and Hepatology, Japanese Red Cross Society Kyoto Daiichi Hospital, Kyoto, Japan
| | - Nobuaki Yagi
- Department of Gastroenterology, Asahi University Hospital, Gifu, Japan
| | - Yuji Naito
- Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan
| | - Yoshito Itoh
- Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan
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14
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Choe YH, Jung DH, Park JC, Kim HY, Shin SK, Lee SK, Lee YC. Prediction model for bleeding after endoscopic submucosal dissection of gastric neoplasms from a high-volume center. J Gastroenterol Hepatol 2021; 36:2217-2223. [PMID: 33646614 DOI: 10.1111/jgh.15478] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/15/2020] [Revised: 12/27/2020] [Accepted: 02/23/2021] [Indexed: 12/15/2022]
Abstract
BACKGROUND AND AIM Bleeding after endoscopic submucosal dissection (ESD) is a main adverse event. To date, although there have been several studies about risk factors for post-ESD bleeding, there has been few predictive model for post-ESD bleeding with large volume cases. We aimed to design a prediction model for post-ESD bleeding using a classification tree model. METHODS We analyzed a prospectively established cohort of patients with gastric neoplasms treated with ESD from 2007 to 2016. Baseline characteristics were collected for a total of 5080 patients, and the bleeding risk was estimated using variable statistical methods such as logistic regression, AdaBoost, and random forest. To investigate how bleeding was affected by independent predictors, the classification and regression tree (CART) method was used. The prediction tree developed for the cohort was internally validated. RESULTS Post-ESD bleeding occurred in 262 of 5080 patients (5.1%). In multivariate logistic regression, ongoing antithrombotic use during the procedure, cancer pathology, and piecemeal resection were significant risk factors for post-ESD bleeding. In the CART model, the decisive variables were ongoing antithrombotic agent use, resected specimen size ≥49 mm, and patient age <62 years. The CART model accuracy was 94.9%, and the cross-validation accuracy was 94.8%. CONCLUSIONS We developed a simple and easy-to-apply predictive tree model based on three risk factors that could help endoscopists identify patients at a high risk of bleeding. This model will enable clinicians to establish precise management strategies for patients at a high risk of bleeding and to prevent post-ESD bleeding.
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Affiliation(s)
- Yeon Hwa Choe
- Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea
| | - Da Hyun Jung
- Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea
| | - Jun Chul Park
- Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea
| | - Ha Yan Kim
- Department of Biomedical Systems Informatics, Biostatistics Collaboration Unit, Yonsei University College of Medicine, Seoul, South Korea
| | - Sung Kwan Shin
- Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea
| | - Sang Kil Lee
- Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea
| | - Yong Chan Lee
- Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea
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15
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Jung Y, Baik GH, Ko WJ, Ko BM, Kim SH, Jang JS, Jang JY, Lee WS, Cho YK, Lim SG, Moon HS, Yoo IK, Cho JY. Diode Laser-Can It Replace the Electrical Current Used in Endoscopic Submucosal Dissection? Clin Endosc 2021; 54:555-562. [PMID: 33435658 PMCID: PMC8357600 DOI: 10.5946/ce.2020.229] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/19/2020] [Revised: 10/09/2020] [Accepted: 10/15/2020] [Indexed: 12/15/2022] Open
Abstract
BACKGROUND/AIMS A new medical fiber-guided diode laser system (FDLS) is expected to offer high-precision cutting with simultaneous hemostasis. Thus, this study aimed to evaluate the feasibility of using the 1,940-nm FDLS to perform endoscopic submucosal dissection (ESD) in the gastrointestinal tract of an animal model. METHODS In this prospective animal pilot study, gastric and colorectal ESD using the FDLS was performed in ex vivo and in vivo porcine models. The completeness of en bloc resection, the procedure time, intraprocedural bleeding, histological injuries to the muscularis propria (MP) layer, and perforation were assessed. RESULTS The en bloc resection and perforation rates in the ex vivo study were 100% (10/10) and 10% (1/10), respectively; those in the in vivo study were 100% (4/4) and 0% for gastric ESD and 100% (4/4) and 25% (1/4) for rectal ESD, respectively. Deep MP layer injuries tended to occur more frequently in the rectal than in the gastric ESD cases, and no intraprocedural bleeding occurred in either group. CONCLUSION The 1,940-nm FDLS was capable of yielding high en bloc resection rates without intraprocedural bleeding during gastric and colorectal ESD in animal models.
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Affiliation(s)
- Yunho Jung
- Department of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea
| | - Gwang Ho Baik
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea
| | - Weon Jin Ko
- Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea
| | - Bong Min Ko
- Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, Korea
| | - Seong Hwan Kim
- Department of Internal Medicine, Nowon Eulji Medical Center, Eulji University College of Medicine, Seoul, Korea
| | - Jin Seok Jang
- Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea
| | - Jae-Young Jang
- Department of Gastroenterology and Hepatology, College of Medicine, Kyung Hee University, Seoul, Korea
| | - Wan-Sik Lee
- Department of Internal Medicine, Chonnam National University Hwasun Hospital, Gwangju, Korea
| | - Young Kwan Cho
- Department of Internal Medicine, Nowon Eulji Medical Center, Eulji University College of Medicine, Seoul, Korea
| | - Sun Gyo Lim
- Department of Gastroenterology, Ajou University School of Medicine, Suwon, Korea
| | - Hee Seok Moon
- Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Korea
| | - In Kyung Yoo
- Division of Gastroenterology, Department of Internal Medicine, CHA Bundang Medical Center, Seongnam, Korea
| | - Joo Young Cho
- Division of Gastroenterology, Department of Internal Medicine, CHA Bundang Medical Center, Seongnam, Korea
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16
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Abiko S, Oda S, Meno A, Shido A, Yoshida S, Yoshikawa A, Harada K, Kawagishi N, Sano I, Oda H, Miyagishima T. Feasibility of a modified search, coagulation, and clipping method with and without the use of polyglycolic acid sheets and fibrin glue for preventing delayed bleeding after gastric endoscopic submucosal dissection. BMC Gastroenterol 2021; 21:63. [PMID: 33573607 PMCID: PMC7879694 DOI: 10.1186/s12876-020-01539-x] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/09/2020] [Accepted: 11/12/2020] [Indexed: 02/07/2023] Open
Abstract
BACKGROUND Methods have been developed for preventing delayed bleeding (DB) after gastric endoscopic submucosal dissection (GESD). However, none of the methods can completely prevent DB. We hypothesized that DB could be prevented by a modified search, coagulation, and clipping (MSCC) method for patients at low risk for DB and by combining the use of polyglycolic acid sheets and fibrin glue with the MSCC method (PMSCC method) for patients at high risk for DB (antibleeding [ABI] strategy). This study assessed the technical feasibility of this novel strategy. METHOD We investigated 123 lesions in 121 consecutive patients who underwent GESD in Kushiro Rosai Hospital between April 2018 and January 2020. The decision for continuation or cessation of antithrombotic agents was based on the Guidelines for Gastroenterological Endoscopy in Patients Undergoing Antithrombotic Treatment. RESULTS Oral antithrombotic agents were administered to 28 patients (22.8%). The en bloc R0 resection rate was 98.4%. The MSCC method and the PMSCC method for preventing DB were performed in 114 and 9 lesions, respectively. The median time of the MSCC method was 16 min, and the median speed (the resection area divided by the time of method used) was 3.6 cm2/10 min. The median time of the PMSCC method was 59 min, and the median speed was 1.3 cm2/10 min. The only delayed procedural adverse event was DB in 1 (0.8%) of the 123 lesions. CONCLUSIONS The ABI strategy is feasible for preventing DB both in patients at low risk and in those at high risk for DB after GESD, whereas the PMSCC method may be necessary for reduction of time.
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Affiliation(s)
- Satoshi Abiko
- Department of Gastroenterology, Kushiro Rosai Hospital, Kushiro, Japan.
- Department of Gastroenterology and Hepatology, Hakodate Municipal Hospital, Hakodate, Japan.
| | - Soichiro Oda
- Department of Gastroenterology, Kushiro Rosai Hospital, Kushiro, Japan
| | - Akimitsu Meno
- Department of Gastroenterology, Kushiro Rosai Hospital, Kushiro, Japan
| | - Akane Shido
- Department of Gastroenterology, Kushiro Rosai Hospital, Kushiro, Japan
| | - Sonoe Yoshida
- Department of Gastroenterology, Kushiro Rosai Hospital, Kushiro, Japan
| | - Ayumu Yoshikawa
- Department of Gastroenterology, Kushiro Rosai Hospital, Kushiro, Japan
| | - Kazuaki Harada
- Department of Gastroenterology, Kushiro Rosai Hospital, Kushiro, Japan
| | - Naoki Kawagishi
- Department of Gastroenterology, Kushiro Rosai Hospital, Kushiro, Japan
| | - Itsuki Sano
- Department of Gastroenterology, Kushiro Rosai Hospital, Kushiro, Japan
| | - Hisashi Oda
- Department of Gastroenterology, Kushiro Rosai Hospital, Kushiro, Japan
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17
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Lin SL, Gao PT, Ni WK, Li QL, Chen WF, Zhang YQ, Hu JW, Qin WZ, Cai MY, Ren Z, Zhong YS, Yao LQ, Chen SY, Xu MD, Ma LL, Zhou PH. Controlled hypertension under hemostasis prevents post-gastric endoscopic submucosal dissection bleeding: a prospective randomized controlled trial. Surg Endosc 2021; 35:5675-5685. [DOI: 10.1007/s00464-020-08256-2] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/16/2020] [Accepted: 12/17/2020] [Indexed: 12/13/2022]
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18
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Saito H, Igarashi K, Hirasawa D, Okuzono T, Suzuki K, Abe Y, Nawata Y, Tanaka Y, Tanaka I, Unno S, Nishikawa Y, Tsubokura M, Nakahori M, Chonan A, Matsuda T. The risks and characteristics of the delayed bleeding after endoscopic submucosal dissection for early gastric carcinoma in cases with anticoagulants. Scand J Gastroenterol 2020; 55:1253-1260. [PMID: 32924673 DOI: 10.1080/00365521.2020.1817542] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
BACKGROUND Endoscopic submucosal dissection (ESD) is a minimally invasive treatment for early gastric carcinoma. Vitamin K antagonists and direct oral anticoagulants (DOAC) were reported to increase the risk of delayed bleeding after ESD. However, the evaluation of ESD cases taking anticoagulants is scarce. We analyzed the risk and characteristics of delayed bleeding after gastric ESD in patients on anticoagulants. METHODS We performed a retrospective observational study at a single center. Consecutive patients who underwent ESD for early gastric carcinoma and took anticoagulants, including warfarin, rivaroxaban, dabigatran, apixaban, and edoxaban, between January 2012 and December 2018, were analyzed. We also calculated delayed bleeding rates for those without anticoagulants. RESULTS Of 1855 eligible patients who underwent gastric ESDs, 143 took anticoagulants. Delayed bleeding occurred in 30 (21.0%) cases taking anticoagulants, with 15 (19.5%) cases in the DOAC group [rivaroxaban, seven cases (21.2%); dabigatran, four cases (20.0%); apixaban, four cases (23.5%); and edoxaban, zero cases (0%)] and 15 cases (22.7%) in the warfarin group. Furthermore, 43/344 (12.5%) patients taking antiplatelets and 76/1368 (5.6%) patients without antithrombic drugs experienced delayed bleeding. Multivariable logistic analysis revealed post-heart valve replacement (OR, 6.56; 95% CI, 1.75-24.7; p < .05) as a risk for delayed bleeding in warfarin-taking patients, while no statistically significant factor was found in DOAC-taking patients. CONCLUSIONS Anticoagulants were associated with a high incidence of severe delayed bleeding. Careful attention should be paid to patients on anticoagulants after gastric ESD, especially those on warfarin after heart valve replacement.
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Affiliation(s)
- Hiroaki Saito
- Department of Gastroenterology, Sendai Kousei Hospital, Sendai, Japan.,Department of Public Health, Fukushima Medical University, Fukushima, Japan
| | - Kimihiro Igarashi
- Department of Gastroenterology, Sendai Kousei Hospital, Sendai, Japan
| | - Dai Hirasawa
- Department of Gastroenterology, Sendai Kousei Hospital, Sendai, Japan
| | - Toru Okuzono
- Department of Gastroenterology, Sendai Kousei Hospital, Sendai, Japan
| | - Kenjiro Suzuki
- Department of Gastroenterology, Sendai Kousei Hospital, Sendai, Japan
| | - Yoko Abe
- Department of Gastroenterology, Sendai Kousei Hospital, Sendai, Japan
| | - Yoshitaka Nawata
- Department of Gastroenterology, Sendai Kousei Hospital, Sendai, Japan
| | - Yukari Tanaka
- Department of Gastroenterology, Sendai Kousei Hospital, Sendai, Japan
| | - Ippei Tanaka
- Department of Gastroenterology, Sendai Kousei Hospital, Sendai, Japan
| | - Shuhei Unno
- Department of Gastroenterology, Sendai Kousei Hospital, Sendai, Japan
| | - Yoshitaka Nishikawa
- Department of Internal Medicine, Hirata Central Hospital, Fukushima, Japan.,Department of Health Informatics, Kyoto University School of Public Health, Kyoto, Japan
| | - Masaharu Tsubokura
- Department of Public Health, Fukushima Medical University, Fukushima, Japan
| | - Masato Nakahori
- Department of Gastroenterology, Sendai Kousei Hospital, Sendai, Japan
| | - Akimichi Chonan
- Department of Gastroenterology, Sendai Kousei Hospital, Sendai, Japan
| | - Tomoki Matsuda
- Department of Gastroenterology, Sendai Kousei Hospital, Sendai, Japan
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19
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Hu J, Liu W, Chen Z, Lin D, Su M, Lan P. A Novel Snare Traction-Assisted Method During Endoscopic Resection for Upper Gastrointestinal Submucosal Tumors. J Laparoendosc Adv Surg Tech A 2020; 31:416-422. [PMID: 32924769 DOI: 10.1089/lap.2020.0462] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/16/2022] Open
Abstract
Background: Traction-assisted endoscopic resection is an approach to provide better procedural outcomes than conventional endoscopic procedure in treating gastric or esophageal epithelial lesions. Submucosal tumors (SMTs) are challenging to resect endoscopically due to the difficulty in exposure and high incidence of full-thickness resection. In this study, we investigated the efficacy of snare traction-assisted method, served as an "extra hand," for upper gastrointestinal SMTs. Methods: From June 2019 to May 2020, we used the snare traction-assisted method to treat 11 patients with 12 upper gastrointestinal SMTs in the Sixth Affiliated Hospital, Sun Yat-sen University. The duration of the procedures and the outcomes were recorded. Results: A total of 11 patients with 12 lesions were treated by snare traction-assisted endoscopic resection. The mean procedure time was 26.8 ± 8.3 minutes. En bloc resection was achieved in all the 12 lesions. The mean length of the specimens was 11.5 ± 4.0 mm. Full-thickness resection was performed in four lesions. The patients were discharged in 5.0 days after procedures without delayed bleeding or other complication reported. Conclusion: Snare traction-assisted method is an effective tool for endoscopic resection of upper gastrointestinal SMTs. Further prospective studies comparing the snare traction-assisted method with the conventional procedure are necessary.
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Affiliation(s)
- Jiancong Hu
- Department of Endoscopic Surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.,Department of Colorectal Surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.,Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, the Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China
| | - Wei Liu
- Department of Endoscopic Surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China
| | - Zexian Chen
- Department of Colorectal Surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.,Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, the Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China
| | - Dezheng Lin
- Department of Endoscopic Surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China
| | - Mingli Su
- Department of Endoscopic Surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China
| | - Ping Lan
- Department of Colorectal Surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.,Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, the Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China
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20
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Minoda Y, Ihara E, Ogino H, Komori K, Otsuka Y, Ikeda H, Esaki M, Chinen T, Matsuguchi T, Takahashi S, Shiga N, Yoshimura R, Ogawa Y. The Efficacy and Safety of a Promising Single-Channel Endoscopic Closure Technique for Endoscopic Treatment-Related Artificial Ulcers: A Pilot Study. Gastrointest Tumors 2020; 7:21-29. [PMID: 32399462 DOI: 10.1159/000503994] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/02/2019] [Accepted: 09/01/2019] [Indexed: 01/07/2023] Open
Abstract
Background/Aims It is important to appropriately manage patients with procedure-related artificial mucosal ulcers or procedure-related complications. Many endoscopic closure techniques have been reported; however, they often require the use of special devices. We developed a single-channel endoscopic closure technique (SCCT) that can be performed with conventional devices. In the present study, we describe the technique and evaluate its efficacy. Methods Twenty-five consecutive patients who underwent endoscopic treatment and whose artificial ulcer was closed using the SCCT were enrolled in this study. The technical success rate, number of clips for closure, procedure time, complication rate on the day of the procedure, clinical success rates on days 1 and 5, and incidence of severe stenosis of the gastrointestinal (GI) tract at 2 months after the procedure were evaluated. Results The median ulcer diameter was 20 mm. The tumor locations were the stomach (n = 19), jejunum (n = 1), and colon (n = 5). The technical success rate was 100% (25/25), and the rate of incomplete closure was 0% (0/25). Eight clips were needed on average. The median procedure time was 18 min (range 5-49 min). The complication rate was 0% (25/25). The clinical success rates on days 1 and 5 were 100% (19/19) and 100% (9/9), respectively. No patients presented stenosis as a late complication at 2 months after the procedure (0/25). Conclusion The SCCT could be applied in the treatment of artificial ulcers in several parts of the GI tract with a high clinical success rate and no complications. The SCCT appears to be a good option for closing artificial mucosal ulcers.
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Affiliation(s)
- Yosuke Minoda
- Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
| | - Eikichi Ihara
- Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
| | - Haruei Ogino
- Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
| | - Keishi Komori
- Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
| | - Yoshihiro Otsuka
- Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
| | - Hiroko Ikeda
- Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
| | - Mitsuru Esaki
- Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
| | - Takatoshi Chinen
- Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
| | - Takahiro Matsuguchi
- Department of Gastroenterology, Harasanshin General Hospital, Fukuoka, Japan
| | | | - Noriko Shiga
- Medical Treatment Corporate Foundation Group Hakuaikai Medical Checkup Center Wellness, Fukuoka, Japan
| | - Rie Yoshimura
- Medical Treatment Corporate Foundation Group Hakuaikai Medical Checkup Center Wellness, Fukuoka, Japan
| | - Yoshihiro Ogawa
- Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
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21
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Minoda Y, Chinen T, Osoegawa T, Itaba S, Haraguchi K, Akiho H, Aso A, Sumida Y, Komori K, Ogino H, Ihara E, Ogawa Y. Superiority of mucosal incision-assisted biopsy over ultrasound-guided fine needle aspiration biopsy in diagnosing small gastric subepithelial lesions: a propensity score matching analysis. BMC Gastroenterol 2020; 20:19. [PMID: 31964357 PMCID: PMC6975081 DOI: 10.1186/s12876-020-1170-2] [Citation(s) in RCA: 23] [Impact Index Per Article: 4.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/22/2019] [Accepted: 01/13/2020] [Indexed: 12/18/2022] Open
Abstract
BACKGROUND Gastric subepithelial lesions, including gastrointestinal stromal tumors, are often found during routine gastroscopy. While endoscopic ultrasound-guided fine-needle aspiration biopsy (EUS-FNAB) has been the gold standard for diagnosing gastric subepithelial lesions, alternative open biopsy procedures, such as mucosal incision-assisted biopsy (MIAB) has been reported useful. The aim of this study is to evaluate the efficacy of MIAB for the diagnosis of gastric SELs compared with EUS-FNAB. METHODS We retrospectively analyzed medical records of 177 consecutive patients with gastric SELs who underwent either MIAB or EUS-FNAB at five hospitals in Japan between January 2010 and January 2018. Diagnostic yield, procedural time, and adverse event rates for the two procedures were evaluated before and after propensity-score matching. RESULTS No major procedure-related adverse events were observed in either group. Both procedures yielded highly-accurate diagnoses once large enough samples were obtained; however, such successful sampling was more often accomplished by MIAB than by EUS-FNAB, especially for small SELs. As a result, MIAB provided better diagnostic yields for SELs smaller than 20-mm diameter. The diagnostic yields of both procedures were comparable for SELs larger than 20-mm diameter; however, MIAB required significantly longer procedural time (approximately 13 min) compared with EUS-FNAB. CONCLUSIONS Although MIAB required longer procedural time, it outperformed EUS-FNAB when diagnosing gastric SELs smaller than 20-mm diameter.
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Affiliation(s)
- Yosuke Minoda
- Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
| | - Takatoshi Chinen
- Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
| | - Takashi Osoegawa
- Department of Gastroenterology, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan
| | - Soichi Itaba
- Department of Gastroenterology, Kyushu Rosai Hospital, Fukuoka, Japan
| | | | - Hirotada Akiho
- Department of Gastroenterology, Kitakyushu Municipal Medical Center, Fukuoka, Japan
| | - Akira Aso
- Department of Gastroenterology, Kitakyushu Municipal Medical Center, Fukuoka, Japan
| | - Yorinobu Sumida
- Department of Gastroenterology, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan
| | - Keishi Komori
- Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
| | - Haruei Ogino
- Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
| | - Eikichi Ihara
- Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
| | - Yoshihiro Ogawa
- Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
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Araújo-Martins M, Pimentel-Nunes P, Libânio D, Borges-Canha M, Dinis-Ribeiro M. How Is Endoscopic Submucosal Dissection for Gastrointestinal Lesions Being Implemented? Results from an International Survey. GE PORTUGUESE JOURNAL OF GASTROENTEROLOGY 2020; 27:1-17. [PMID: 31970235 PMCID: PMC6959092 DOI: 10.1159/000501404] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 03/28/2019] [Accepted: 05/11/2019] [Indexed: 12/19/2022]
Abstract
BACKGROUND AND STUDY AIM Superficial gastrointestinal (GI) neoplasms can be treated with endoscopic mucosal resection (EMR) and/or endoscopic submucosal dissection (ESD). These techniques are widely used in Eastern countries; however, its use in the West is limited. The aim of this study was to evaluate the current implementation of ESD in Western countries. METHODS Western endoscopists (n = 279) who published papers related to EMR/ESD between 2005 and 2017 were asked to complete an online survey from December 2017 to February 2018. RESULTS A total of 58 endoscopists (21%) completed the survey. Thirty performed ESD in the esophagus (52%), 45 in the stomach (78%), 36 in the co-lorectum (62%), and 6 in the duodenum (10%). The median total number of lesions ever treated per endoscopist was 190, with a median number per endoscopist in 2016 of 41 (7 [IQR 1-21], 6 [IQR 4-16], and 28 [5-63] in the esophagus, in the stomach, and in the colon and rectum, respectively). En bloc resection rates were 97% in the esophagus, 95% in the stomach, and 84% in the colorectum. Complete resection (R0) was achieved in 88, 91, and 81%, respectively. Curative rates were 69, 70, and 67%, respectively. Major complications (perforation or delayed bleeding) occurred more often in colorectal ESD (12 vs. 6% in the esophagus and 7% in the stomach). In the upper GI tract, the majority of resected lesions were intramucosal adenocarcinoma (59% in the esophagus; 47% in the stomach), while in the colorectum the majority were adenomas (59%). CONCLUSION ESD seems to be performed by a large number of centers and endoscopists. Our results suggest that ESD is being successfully implemented in Western countries, achieving a good rate of efficacy and safety according to European guidelines.
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Affiliation(s)
- Miguel Araújo-Martins
- Department of Surgery and Physiology, Faculty of Medicine, University of Porto, Porto, Portugal
| | - Pedro Pimentel-Nunes
- Department of Gastroenterology, Portuguese Oncology Institute of Porto, Porto, Portugal
- Center for Research in Health Technologies and Information Systems (CINTESIS), Faculty of Medicine, University of Porto, Porto, Portugal
- Department of Surgery and Physiology, Faculty of Medicine, University of Porto, Porto, Portugal
| | - Diogo Libânio
- Department of Gastroenterology, Portuguese Oncology Institute of Porto, Porto, Portugal
- Center for Research in Health Technologies and Information Systems (CINTESIS), Faculty of Medicine, University of Porto, Porto, Portugal
| | - Marta Borges-Canha
- Department of Surgery and Physiology, Faculty of Medicine, University of Porto, Porto, Portugal
| | - Mário Dinis-Ribeiro
- Department of Gastroenterology, Portuguese Oncology Institute of Porto, Porto, Portugal
- Center for Research in Health Technologies and Information Systems (CINTESIS), Faculty of Medicine, University of Porto, Porto, Portugal
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Effectiveness of fibrin sealant as hemostatic technique in accelerating ESD-induced ulcer healing: a retrospective study. Surg Endosc 2019; 34:1191-1199. [PMID: 31236721 DOI: 10.1007/s00464-019-06872-1] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/10/2018] [Accepted: 05/20/2019] [Indexed: 02/07/2023]
Abstract
OBJECTIVES Healing of gastric endoscopic submucosal dissection (ESD)-induced ulcer is critical for patient recovery. During ESD treatment, submucosal incisions are made with an electrosurgical knife to accomplish en bloc resections of superficial lesions. Nevertheless, excess electrocoagulation may decrease the blood supply of ESD-induced ulcer and delay the ulcer healing. The aim of this retrospective study was to evaluate the effectiveness of conservative electrocoagulation followed by porcine fibrin sealant (FS) as a wound microvessels-protective hemostatic technique in promoting the healing of ESD-induced ulcer. METHODS A total of 332 patients with early gastric cancer (EGCs), or gastric precancerous lesion and gastric adenoma were retrospectively analyzed. Propensity score matching was used to compensate for the differences in age, gender, tumor location, resected specimen area, and pathology. One-month ulcer healing rates and delayed bleeding were compared between two matched groups (combined hemostats group and electrocautery group). RESULTS A total of 115 matched pairs were created after propensity score matching. There was no difference in tumor location, specimen surface area, tumor differentiation and invasion depth between groups. The completed healing rate 1 month after ESD was 44.3% in combined hemostats group and 30.4% in electrocautery group (P = 0.004). There was no difference in delayed massive bleeding rate between two groups (P = 0.300). In addition, based on the multivariate regression analysis for ulcer healing rate, the use of FS (OR, 0.348, 95% CI 0.196 - 0.617, P = 0.000) and larger specimen size (OR, 2.640, 95% CI 2.015-3.458, P = 0.000) were associated with nonhealing ulcer 1 month after ESD. CONCLUSION Applying conservative electrocoagulation followed by porcine FS as a wound microvessels-protective hemostatic technique can promote ESD-induced ulcer healing without increasing delayed bleeding.
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24
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Risk factors for delayed bleeding by onset time after endoscopic submucosal dissection for gastric neoplasm. Sci Rep 2019; 9:2674. [PMID: 30804386 PMCID: PMC6389879 DOI: 10.1038/s41598-019-39381-1] [Citation(s) in RCA: 36] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/19/2018] [Accepted: 01/21/2019] [Indexed: 02/07/2023] Open
Abstract
Post-endoscopic submucosal dissection bleeding (PEB) is one of the important complications after endoscopic submucosal dissection (ESD), but still difficult to predict. The present study aimed to identify significant risk factors for PEB according to onset time. Between November 2008 and January 2016, a total of 1864 lesions resected via ESD were analyzed. PEB was classified as either early or late according to onset time (within or after 24 hours post-ESD, respectively). During second-look endoscopy, the artificial ulcer bed was subjected to Forrest classification. A high risk of stigma was defined as active spurting bleeding, oozing bleeding, and a non-bleeding visible vessel in the ulcer. The endoscopic factors and medications associated with PEB were analyzed. PEB occurred in 77 lesions (4.1%): early only in 46 (2.4%), late only in 22 (1.1%), and early and late in 9 (0.4%). Among 55 early PEB events, 25 were asymptomatic and diagnosed during second-look endoscopy. Age ≤65 years, resection size ≥30 mm, procedure time ≥20 min, lower third of the stomach, erosion, and clopidogrel use were significantly associated with early PEB. If the number of risk factors were ≤1, the risk of early PEB was 0.6%. For late PEB, the mid to upper third of the stomach, undifferentiated carcinoma, erosion, high risk of stigma during second-look endoscopy, history of early PEB, and clopidogrel use were significant risk factors. If risk factors were absent, the risk of late PEB was 0.1%. For patients at high risk of early PEB, selective second-look endoscopy might be a useful. For patients at high risk of late PEB, careful monitoring of bleeding should be considered.
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25
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Hamada K, Uedo N, Tonai Y, Arao M, Suzuki S, Iwatsubo T, Kato M, Shichijo S, Yamasaki Y, Matsuura N, Nakahira H, Kanesaka T, Yamamoto S, Akasaka T, Hanaoka N, Takeuchi Y, Higashino K, Ishihara R, Okada H, Iishi H, Fukui K, Shimokawa T. Efficacy of vonoprazan in prevention of bleeding from endoscopic submucosal dissection-induced gastric ulcers: a prospective randomized phase II study. J Gastroenterol 2019; 54:122-130. [PMID: 29943163 DOI: 10.1007/s00535-018-1487-6] [Citation(s) in RCA: 36] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/24/2018] [Accepted: 06/13/2018] [Indexed: 02/04/2023]
Abstract
BACKGROUND Vonoprazan, potassium-competitive acid blocker, is expected to reduce incidence of delayed bleeding after gastric endoscopic submucosal dissection (ESD); however, preliminary data to design a large-scale comparative study are lacking. This study aimed to assess the efficacy of vonoprazan in preventing delayed bleeding after gastric ESD. METHODS In this single-center randomized phase II trial, a modified screened selection design was used with a threshold non-bleeding rate of 89% and an expected rate of 97%. In this design, Simon's optimal two-stage design was first applied for each parallel group, and efficacy was evaluated in comparison with the threshold rate using binomial testing. Patients were randomly assigned in a 1:1 ratio to receive either vonoprazan 20 mg (VPZ group) or lansoprazole 30 mg (PPI group) for 8 weeks from the day before gastric ESD. The primary endpoint was the incidence of delayed bleeding, defined as endoscopically confirmed bleeding accompanied by hematemesis, melena, or a decrease in hemoglobin of ≥ 2 g/dl. RESULTS Delayed bleeding occurred in three of 69 patients (4.3%, 95% CI 0.9-12.2%, p = 0.047) in the VPZ group, and four of 70 (5.7%, 95% CI 1.6-14.0%, p = 0.104) in the PPI group. As only vonoprazan showed significant reduction in delayed bleeding compared with the threshold rate, it was determined to be efficacious treatment. CONCLUSIONS Vonoprazan efficaciously reduced the delayed bleeding rate in patients with an ESD-induced gastric ulcer. A large-scale, randomized, phase III study is warranted to definitively test the effectiveness of vonoprazan compared with proton pump inhibitors.
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Affiliation(s)
- Kenta Hamada
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
- Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
| | - Noriya Uedo
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan.
| | - Yusuke Tonai
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Masamichi Arao
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Sho Suzuki
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Taro Iwatsubo
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Minoru Kato
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Satoki Shichijo
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Yasushi Yamasaki
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
- Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
| | - Noriko Matsuura
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Hiroko Nakahira
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Takashi Kanesaka
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Sachiko Yamamoto
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Tomofumi Akasaka
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Noboru Hanaoka
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Yoji Takeuchi
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Koji Higashino
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Ryu Ishihara
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Hiroyuki Okada
- Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
| | - Hiroyasu Iishi
- Department of Gastrointestinal Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan
| | - Keisuke Fukui
- Department of Cancer Control and Statistics, Osaka International Cancer Institute, Osaka, Japan
| | - Toshio Shimokawa
- Clinical Study Support Center, Wakayama Medical University, Wakayama, Japan
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Lee BE, Kim GH, Song GA, Seo JH, Jeon HK, Baek DH, Kim DU. Continuous Infusion versus Intermittent Dosing with Pantoprazole for Gastric Endoscopic Submucosal Dissection. Gut Liver 2019; 13:40-47. [PMID: 30400726 PMCID: PMC6347001 DOI: 10.5009/gnl18222] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/07/2018] [Revised: 07/20/2018] [Accepted: 07/23/2018] [Indexed: 12/27/2022] Open
Abstract
BACKGROUND/AIMS Proton pump inhibitors are widely used to prevent gastric endoscopic submucosal dissection (ESD)-related bleeding, but no standard administration regimens have been established. We aimed to prospectively compare the effects of continuous infusion and intermittent dosing with pantoprazole on preventing gastric ESD-related bleeding. Additionally, we analyzed the risk factors for bleeding. METHODS From April 2012 to May 2013, patients with a gastric epithelial neoplasm scheduled for ESD in the Pusan National University Hospital were randomly assigned to one of two groups according to the pantoprazole administration regimen (continuous infusion or intermittent dosing). The primary outcomes measured were intra- and postprocedural bleeding events. RESULTS The final analysis included 401 patients. The rate of significant intraprocedural bleeding was 25.4% in the C group and 24.0% in the I group, with no significant difference (p=0.419). In addition, there was no significant difference in the postprocedural bleeding rate between the C and I groups (11.7% vs 10.2%, p=0.374). Multivariate analysis showed that intraprocedural bleeding was associated with the proximal tumor location, the presence of fibrosis, and the size of the resected specimen, whereas postprocedural bleeding was associated with the size of the resected specimen and the procedure/coagulation time. CONCLUSIONS Intermittent dosing with pantoprazole is sufficient and cost-effective for the prevention of gastric ESD-related bleeding. Operators should consider tumor characteristics when planning ESD to minimize the risk of intraprocedural bleeding, and patients with large iatrogenic ulcers should be carefully monitored for postprocedural bleeding.
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Affiliation(s)
- Bong Eun Lee
- Department of Internal Medicine, Biomedical Research Institute, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Korea
| | - Gwang Ha Kim
- Department of Internal Medicine, Biomedical Research Institute, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Korea
| | - Geun Am Song
- Department of Internal Medicine, Biomedical Research Institute, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Korea
| | - Jong Hun Seo
- Department of Internal Medicine, Biomedical Research Institute, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Korea
| | - Hye Kyung Jeon
- Department of Internal Medicine, Biomedical Research Institute, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Korea
| | - Dong Hoon Baek
- Department of Internal Medicine, Biomedical Research Institute, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Korea
| | - Dong Uk Kim
- Department of Internal Medicine, Biomedical Research Institute, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Korea
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Baldaque-Silva F, Marques M, Andrade AP, Sousa N, Lopes J, Carneiro F, Macedo G. Endoscopic submucosal dissection of gastrointestinal lesions on an outpatient basis. United European Gastroenterol J 2019; 7:326-334. [PMID: 31080617 DOI: 10.1177/2050640618823874] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/02/2018] [Accepted: 12/12/2018] [Indexed: 12/13/2022] Open
Abstract
Background Endoscopic submucosal dissection (ESD) is usually associated with hospital admission. Objectives To evaluate, prospectively, the feasibility, safety and efficacy of outpatient gastrointestinal ESD. Methods Patients with suitable lesions were invited to participate. Those that dwelt more than 1 hour from the hospital, lived alone, had severe co-morbidities, were <18 years old, had duodenal lesions, or that had ESD-related complications were admitted. The remaining patients were discharged if no complications were detected. A patients' inquiry was performed. Results Of the 164 ESD patients, 122 were outpatient-based, corresponding to 115 patients, 47% male and mean age 63 ± 12 years-old. Outpatients tended to be younger, female, to have gastric lesions, less advanced lesions, and shorter and less complicated ESDs (all p < 0.05). Outpatients' mean tumour size was 38 mm, en bloc and R0 resection rates were 88 and 78%, respectively. Seven ESD outpatients (5.7%) had complications: delayed bleeding (n = 4), pneumonitis (n = 2) or emphysema (n = 1), all managed conservatively. Colorectal location of the lesions was predictive of hospital admission (p = 0.03). In total, 97% of patients were satisfied with the outpatient strategy. Conclusion Risks of ambulatory ESD are low and complications can be successfully managed. This strategy has high patient satisfaction. More studies are needed to evaluate its implications on costs and patients' management.
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Affiliation(s)
- Francisco Baldaque-Silva
- Department of Digestive Diseases, Karolinska University Hospital and Karolinska Institute, Stockholm, Sweden.,Department of Gastroenterology, São João University Hospital, Porto, Portugal
| | - Margarida Marques
- Department of Gastroenterology, São João University Hospital, Porto, Portugal
| | | | - Nuno Sousa
- Department of Biomedical Sciences and Medicine, University of Algarve, Faro, Portugal
| | - Joanne Lopes
- Department of Pathology, São João University Hospital, Porto, Portugal
| | - Fatima Carneiro
- Department of Pathology, São João University Hospital, Porto, Portugal.,Institute of Molecular Pathology and Immunology, University of Porto, Porto, Portugal
| | - Guilherme Macedo
- Department of Gastroenterology, São João University Hospital, Porto, Portugal
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Azumi M, Takeuchi M, Koseki Y, Kumagai M, Kobayashi Y, Takatsuna M, Yoshioka A, Yoshikawa S, Miura T, Terai S. The search, coagulation, and clipping (SCC) method prevents delayed bleeding after gastric endoscopic submucosal dissection. Gastric Cancer 2019; 22:567-575. [PMID: 30267178 PMCID: PMC6476836 DOI: 10.1007/s10120-018-0878-y] [Citation(s) in RCA: 20] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/20/2018] [Accepted: 09/18/2018] [Indexed: 02/07/2023]
Abstract
BACKGROUND Delayed bleeding is an important complication after gastric endoscopic submucosal dissection (ESD). The search, coagulation, and clipping (SCC) method can be used to prevent delayed bleeding after ESD. However, its safety and efficacy are unclear. We compared the SCC method with post-ESD coagulation (PEC) to clarify the safety and efficacy of the SCC method for preventing delayed bleeding after gastric ESD. METHODS This retrospective study included 438 patients (478 lesions) who underwent gastric ESD. Multivariate logistic regression analysis was performed to identify the significant independent factors associated with delayed bleeding and we performed propensity-score matching (PSM) to reduce the effect of procedure-selection bias of SCC method. RESULTS Of the 438 patients, 216 underwent PEC and 222 underwent SCC. Delayed bleeding was significantly less common in the SCC than in the PEC (2.6% vs. 7.2%; P = 0.013). Among patients treated with antithrombotic therapy, the delayed bleeding rate was lower in the SCC group than in the PEC group; however, the difference was not significant (P = 0.15). The SCC method was found to be a significant independent factor for the prevention of delayed bleeding. PSM was performed in 156 patients in the PEC group and SCC group. There was a significant difference in the incidence of bleeding in the PEC and SCC groups (P = 0.013). No patient had perforation/bleeding associated with the SCC method. CONCLUSIONS Our findings suggest that the SCC method is a simple, safe, and effective approach for preventing delayed bleeding after gastric ESD.
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Affiliation(s)
- Motoi Azumi
- 0000 0004 1774 7290grid.416384.cDivision of Gastroenterology and Hepatology, Nagaoka Red Cross Hospital, 2-297-1, Chiaki, Nagaoka, Niigata 940-2085 Japan
| | - Manabu Takeuchi
- 0000 0004 1774 7290grid.416384.cDivision of Gastroenterology and Hepatology, Nagaoka Red Cross Hospital, 2-297-1, Chiaki, Nagaoka, Niigata 940-2085 Japan
| | - Youhei Koseki
- 0000 0004 1774 7290grid.416384.cDivision of Gastroenterology and Hepatology, Nagaoka Red Cross Hospital, 2-297-1, Chiaki, Nagaoka, Niigata 940-2085 Japan
| | - Masaru Kumagai
- 0000 0004 1774 7290grid.416384.cDivision of Gastroenterology and Hepatology, Nagaoka Red Cross Hospital, 2-297-1, Chiaki, Nagaoka, Niigata 940-2085 Japan
| | - Yoko Kobayashi
- 0000 0004 1774 7290grid.416384.cDivision of Gastroenterology and Hepatology, Nagaoka Red Cross Hospital, 2-297-1, Chiaki, Nagaoka, Niigata 940-2085 Japan
| | - Masafumi Takatsuna
- 0000 0004 1774 7290grid.416384.cDivision of Gastroenterology and Hepatology, Nagaoka Red Cross Hospital, 2-297-1, Chiaki, Nagaoka, Niigata 940-2085 Japan
| | - Aiko Yoshioka
- 0000 0004 1774 7290grid.416384.cDivision of Gastroenterology and Hepatology, Nagaoka Red Cross Hospital, 2-297-1, Chiaki, Nagaoka, Niigata 940-2085 Japan
| | - Seiichi Yoshikawa
- 0000 0004 1774 7290grid.416384.cDivision of Gastroenterology and Hepatology, Nagaoka Red Cross Hospital, 2-297-1, Chiaki, Nagaoka, Niigata 940-2085 Japan
| | - Tsutomu Miura
- 0000 0004 1774 7290grid.416384.cDivision of Gastroenterology and Hepatology, Nagaoka Red Cross Hospital, 2-297-1, Chiaki, Nagaoka, Niigata 940-2085 Japan
| | - Shuji Terai
- 0000 0001 0671 5144grid.260975.fDivision of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Niigata University, Niigata, Japan
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Purchiaroni F, Costamagna G, Hassan C. Quality in upper gastrointestinal endoscopic submucosal dissection. ANNALS OF TRANSLATIONAL MEDICINE 2018; 6:261. [PMID: 30094247 PMCID: PMC6064797 DOI: 10.21037/atm.2018.02.27] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 01/29/2018] [Accepted: 02/09/2018] [Indexed: 12/27/2022]
Abstract
Progress in the endoscopy technology field led to an increase in the diagnosis of early gastrointestinal (GI) superficial lesions and to an improvement of their treatment. Endoscopic submucosal dissection (ESD) has been developed in Japan with the aim of removing such lesions in one piece, in order to obtain a curative resection and to minimize the risk of local recurrence, and to preserve the native organ. ESD is widely used in Asia for the treatment of early upper and lower GI lesions and is currently gaining attention in Western countries too. However, ESD can be safely performed only by expert endoscopists and in specific clinical settings. Therefore, prior to decide whether ESD is feasible or not, the target lesion must be carefully assessed, in order to understand whether or not it is eligible for submucosal dissection. The aim of this paper is to review indications, limitations and technical aspects of upper GI ESD.
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Affiliation(s)
- Flaminia Purchiaroni
- Digestive Endoscopy Unit, Fondazione Policlinico A. Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy
| | - Guido Costamagna
- Digestive Endoscopy Unit, Fondazione Policlinico A. Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy
| | - Cesare Hassan
- Digestive Endoscopy Unit, Ospedale Nuova Regina Margherita, Rome, Italy
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Ueki N, Futagami S, Akimoto T, Maruki Y, Yamawaki H, Kodaka Y, Nagoya H, Shindo T, Kusunoki M, Kawagoe T, Gudis K, Miyake K, Iwakiri K. Effect of Antithrombotic Therapy and Long Endoscopic Submucosal Dissection Procedure Time on Early and Delayed Postoperative Bleeding. Digestion 2018; 96:21-28. [PMID: 28609771 DOI: 10.1159/000475924] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/07/2016] [Accepted: 04/21/2017] [Indexed: 02/04/2023]
Abstract
BACKGROUND Recent updated guidelines of the Japanese Society of Gastroenterology recommend the use of a single dose of antiplatelet agents in patients undergoing endoscopic submucosal dissection (ESD). However, the postoperative bleeding risk after gastric ESD associated with the continuation or interruption of antithrombotic therapy remains controversial. We aimed to evaluate whether certain factors including interrupted antithrombotic therapy could affect early and delayed post-ESD bleeding risk. METHODS Three hundred sixty-four patients with gastric neoplasms were treated with ESD at our hospital between October 2005 and December 2012. Seventy-four patients with interrupted antithrombotic therapy were undertaken with ESD. Early and delayed postoperative bleeding patterns were estimated. Various clinical characteristics such as gender, age, tumor location, tumor size, ESD procedure time, platelet count, and comorbidity were evaluated. RESULTS There was a significant difference (p = 0.042) in the ESD procedure time between the patients with postoperative bleeding and those without it. There was no significant difference in postoperative bleeding between the patients on antithrombotic therapy and not on it. Moreover, interrupted antithrombotic therapy and platelet count were significantly (p = 0.0461 and p = 0.0059, respectively) associated with early postoperative bleeding in multivariate analysis. In addition, in univariate analysis, ESD procedure time was significantly (p = 0.041) associated with delayed postoperative bleeding. CONCLUSIONS Antithrombotic therapy and prolonged ESD procedure time were significantly associated with early and delayed postoperative bleeding, respectively.
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Affiliation(s)
- Nobue Ueki
- Department of Internal Medicine, Division of Gastroenterology, Nippon Medical School, Tokyo, Japan
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Lee JY, Kim CG, Cho SJ, Kim YI, Choi IJ. Is the Reinitiation of Antiplatelet Agents Safe at 1 Week after Gastric Endoscopic Submucosal Dissection? Assessment of Bleeding Risk Using the Forrest Classification. Gut Liver 2018; 11:489-496. [PMID: 28335100 PMCID: PMC5491083 DOI: 10.5009/gnl16232] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/06/2016] [Revised: 08/19/2016] [Accepted: 10/11/2016] [Indexed: 12/13/2022] Open
Abstract
Background/Aims Delayed bleeding after gastric endoscopic submucosal dissection (ESD) commonly occurs within 3 days, but it may also occur after 1 week following ESD, especially in antiplatelet agent users. We evaluated the risk of delayed bleeding in post-ESD ulcers using the Forrest classification. Methods Registry data on the Forrest classification of post-ESD ulcers (n=371) at 1 week or 2 weeks after ESD were retrospectively evaluated. The Forrest classification was categorized into two groups: increased risk (Forrest Ia to IIc) or low risk (Forrest III). The odds ratios (ORs) were calculated using logistic regression analysis. Results Among 371 post-ESD ulcers, one ulcer (0.3%) was classified as Forrest Ib, two (0.5%) as Forrest IIa, 17 (4.6%) as Forrest IIb, 172 (46.4%) as Forrest IIc, and 179 (48.2%) as Forrest III. The proportion of increased-risk ulcers was 72.2% (140/194) at 1 week after ESD, which decreased to 29.4% (52/177) at 2 weeks after ESD (p<0.001). In the multivariate analysis, a post-ESD ulcer at 1 week after ESD (OR, 7.54), younger age (OR, 2.17), and upper/middle ulcer location (OR, 2.05) were associated with increased-risk ulcers. Conclusions One week after ESD, ulcers still have an increased risk of bleeding when assessed using the Forrest classification. This risk should be considered when resuming antiplatelet therapy.
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Affiliation(s)
- Jong Yeul Lee
- Center for Gastric Cancer, National Cancer Center, Goyang, Korea
| | - Chan Gyoo Kim
- Center for Gastric Cancer, National Cancer Center, Goyang, Korea
| | - Soo-Jeong Cho
- Center for Gastric Cancer, National Cancer Center, Goyang, Korea
| | - Young-Il Kim
- Center for Gastric Cancer, National Cancer Center, Goyang, Korea
| | - Il Ju Choi
- Center for Gastric Cancer, National Cancer Center, Goyang, Korea
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Izumikawa K, Iwamuro M, Inaba T, Ishikawa S, Kuwaki K, Sakakihara I, Yamamoto K, Takahashi S, Tanaka S, Wato M, Okada H. Bleeding in patients who underwent scheduled second-look endoscopy 5 days after endoscopic submucosal dissection for gastric lesions. BMC Gastroenterol 2018; 18:46. [PMID: 29631560 PMCID: PMC5892005 DOI: 10.1186/s12876-018-0774-2] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/08/2018] [Accepted: 03/28/2018] [Indexed: 02/07/2023] Open
Abstract
BACKGROUND Bleeding after endoscopic submucosal dissection (ESD) in antithrombotic drug users is still one of the important issues to be solved. We performed scheduled second-look endoscopy (SLE) 5 days after ESD, when the resumption of antithrombotic agents is assumed to have achieved a steady state, rather than on the day after ESD. We investigated bleeding incidence and the status of ulcers. METHODS A total of 299 lesions in 299 patients subjected to ESD for gastric neoplasms were enrolled. A double dose of proton pump inhibitors was administered after ESD. SLE was planned 5 days after ESD. Post-ESD bleeding occurring before SLE was defined as early phase post-ESD bleeding, whereas bleeding after SLE was defined as later phase post-ESD bleeding. Forrest IIa and IIb ulcers are defined as high-risk ulcers requiring prophylactic hemostasis. We investigated risk factors for post-ESD bleeding, particularly focusing on the use of antithrombotic agents and the presence of high-risk ulcers requiring prophylactic hemostasis during SLE. RESULTS Under a double dose of proton pump inhibitors, early phase post-ESD bleeding occurred in 2.3% of non-users (5/218) and 6.2% of users of antithrombotic agents (5/81). High-risk ulcers were found in 19.0% of the cases during scheduled SLE (55/289). Later phase bleeding occurred in 5.5% of cases [2.8% of non-users (6/213) and 13.2% of users of antithrombotic agents (10/76)]. Cox regression analysis revealed that the risk factor for post-ESD bleeding was antithrombotic treatment (HR: 3.56; 95% CI: 1.63-8.02, p = 0.002) alone. Among patients with high-risk ulcers, a statistically significant increase in bleeding was observed in the later phase in patients under antithrombotic therapy, compared to those not receiving any antithrombotic agents (p = 0.001). CONCLUSIONS Antithrombotic treatment is a risk factor for post-ESD bleeding despite SLE being scheduled 5 days after ESD. Later phase post-ESD bleeding was observed in 13.2% of the patients under antithrombotic treatment even after prophylactic hemostasis for high-risk ulcers. TRIAL REGISTRATION This study was registered in the UMIN Clinical Trials Registry System ( 000023306 ). Retrospectively registered on 23rd July 2016.
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Affiliation(s)
- Koichi Izumikawa
- Department of Gastroenterology, Kagawa Prefectural Central Hospital, 1-2-2 Asahi-machi, Takamatsu, Kagawa 760-8557 Japan
| | - Masaya Iwamuro
- Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, 2-5-1 Shikata-cho, Kita-ku, Okayama, Okayama 700-8558 Japan
| | - Tomoki Inaba
- Department of Gastroenterology, Kagawa Prefectural Central Hospital, 1-2-2 Asahi-machi, Takamatsu, Kagawa 760-8557 Japan
| | - Shigenao Ishikawa
- Department of Gastroenterology, Kagawa Prefectural Central Hospital, 1-2-2 Asahi-machi, Takamatsu, Kagawa 760-8557 Japan
| | - Kenji Kuwaki
- Department of Internal Medicine, Fukuyama City Hospital, 5-23-1 Zao-cho, Fukuyama, Hiroshima 721-8511 Japan
| | - Ichiro Sakakihara
- Department of Gastroenterology, Kagawa Prefectural Central Hospital, 1-2-2 Asahi-machi, Takamatsu, Kagawa 760-8557 Japan
| | - Kumiko Yamamoto
- Department of Gastroenterology, Kagawa Prefectural Central Hospital, 1-2-2 Asahi-machi, Takamatsu, Kagawa 760-8557 Japan
| | - Sakuma Takahashi
- Department of Gastroenterology, Kagawa Prefectural Central Hospital, 1-2-2 Asahi-machi, Takamatsu, Kagawa 760-8557 Japan
| | - Shigetomi Tanaka
- Department of Gastroenterology, Kagawa Prefectural Central Hospital, 1-2-2 Asahi-machi, Takamatsu, Kagawa 760-8557 Japan
| | - Masaki Wato
- Department of Gastroenterology, Kagawa Prefectural Central Hospital, 1-2-2 Asahi-machi, Takamatsu, Kagawa 760-8557 Japan
| | - Hiroyuki Okada
- Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, 2-5-1 Shikata-cho, Kita-ku, Okayama, Okayama 700-8558 Japan
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Hondo FY, Kishi H, Safatle-Ribeiro AV, Pessorrusso FCS, Ribeiro U, Maluf-Filho F. CHARACTERIZATION OF THE MUCIN PHENOTYPE CAN PREDICT GASTRIC CANCER RECURRENCE AFTER ENDOSCOPIC MUCOSAL RESECTION. ARQUIVOS DE GASTROENTEROLOGIA 2017; 54:308-314. [PMID: 28954038 DOI: 10.1590/s0004-2803.201700000-38] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 02/06/2017] [Accepted: 05/22/2017] [Indexed: 01/27/2023]
Abstract
BACKGROUND Endoscopic mucosal resection is still considered an accepted treatment for early gastric cancer for selected cases. Histopathologic criteria for curative endoscopic resection are intramucosal well-differentiated adenocarcinoma, lateral and deep margins free of tumor, no histological ulceration, and no venous or lymphatic embolism. A 5% local recurrence rate has been described even when all the above-mentioned criteria are met. On the other hand, antigen expression by tumoral cells has been related to the biological behavior of several tumors. OBJECTIVE To evaluate whether early gastric cancer mucin immunoexpression, p53 and Ki-67, can predict recurrence after endoscopic mucosal resection, even when standard histopathologic criteria for curative measures have been attempted. METHODS Twenty-two patients with early gastric cancer were considered to have been completely resected by endoscopic mucosal resection. Local recurrence occurred in 5/22 (22.7%). Immunohistochemical study was possible in 18 (81.8%) resected specimens. Patients were divided in two groups: those with and those without local recurrence. They were compared across demographic, endoscopic, histologic data, and immunohistochemical factors for MUC2, MUC5a, CD10, p53, and Ki-67. RESULTS Mucin immunoexpression allowed a reclassification of gastric adenocarcinoma in intestinal (10), gastric (2), mixed (4), and null phenotypes (2). Mixed phenotype (positive for both MUC2 and MUC5a) was found in 80% of cases in the local recurrence group, while the intestinal type (positive MUC2 and negative MUC5a) was found in 76.9% of cases without local recurrence (P=0.004). Other observed features did not correlate with neoplastic recurrence. CONCLUSION The mixed phenotype of early gastric adenocarcinoma is associated with a higher probability of local recurrence after endoscopic mucosal resection.
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Affiliation(s)
- Fabio Yuji Hondo
- Gastrocirurgia, Faculdade de Medicina, Universidade de São Paulo, SP, Brazil
| | - Humberto Kishi
- Patologia, Faculdade de Medicina, Universidade de São Paulo, SP, Brazil
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Akimoto T, Goto O, Nishizawa T, Yahagi N. Endoscopic closure after intraluminal surgery. Dig Endosc 2017; 29:547-558. [PMID: 28181699 DOI: 10.1111/den.12839] [Citation(s) in RCA: 33] [Impact Index Per Article: 4.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/05/2016] [Accepted: 02/06/2017] [Indexed: 02/06/2023]
Abstract
Endoscopic submucosal dissection is established as a curative endoscopic method for gastrointestinal epithelial neoplasms with a high possibility of complete en bloc resection; however, postoperative adverse events of bleeding and delayed perforation remain. To prevent or minimize them, several techniques for endoscopic mucosal closure have been introduced, such as using endoscopic clips, combined use of hemoclips and supplement devices, and specially designed endoscopic suturing devices. Furthermore, endoscopic full-thickness suturing technique for gastrointestinal wall defect has been developed based on the concept in natural orifice transluminal endoscopic surgery and endoscopic full-thickness resection. Several closure techniques, including over-the-scope clip, threaded bars inserted in a hollow needle, stitches or staplers, and a curved needle and thread are reported. Secure closure of the iatrogenic defect may further expand the range of therapeutic endoscopy. Accumulation of evidence for the efficacy of endoscopic closure and establishment of these techniques are desired.
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Affiliation(s)
- Teppei Akimoto
- Division of Research and Development for Minimally Invasive Treatment, Cancer Center, School of Medicine, Keio University, Tokyo, Japan
| | - Osamu Goto
- Division of Research and Development for Minimally Invasive Treatment, Cancer Center, School of Medicine, Keio University, Tokyo, Japan
| | - Toshihiro Nishizawa
- Division of Research and Development for Minimally Invasive Treatment, Cancer Center, School of Medicine, Keio University, Tokyo, Japan
| | - Naohisa Yahagi
- Division of Research and Development for Minimally Invasive Treatment, Cancer Center, School of Medicine, Keio University, Tokyo, Japan
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Kim EH, Park SW, Nam E, Eun CS, Han DS, Park CH. Role of second-look endoscopy and prophylactic hemostasis after gastric endoscopic submucosal dissection: A systematic review and meta-analysis. J Gastroenterol Hepatol 2017; 32:756-768. [PMID: 27796052 DOI: 10.1111/jgh.13623] [Citation(s) in RCA: 22] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/18/2016] [Revised: 10/17/2016] [Accepted: 10/18/2016] [Indexed: 02/07/2023]
Abstract
BACKGROUND Although several studies have shown that second-look endoscopy does not affect the incidence of bleeding after gastric endoscopic submucosal dissection (ESD), the potential roles of second-look endoscopy have not been fully evaluated. This study aimed to determine the role of second-look endoscopy after ESD through a systematic review and meta-analysis. METHODS This study conducted a systematic literature search of MEDLINE, EMBASE, and the Cochrane Library through March 2016 using the keywords "second-look," "prophylactic hemostasis," "prophylactic haemostasis," "prevention," "prophylaxis," and "endoscopic submucosal dissection." Studies were included if they evaluated the incidence of post-ESD bleeding according to second-look endoscopy or prophylactic hemostasis during second-look endoscopy. RESULTS Four randomized controlled trials on post-ESD bleeding between second-look endoscopy and no second-look endoscopy and 12 non-randomized studies with a cohort design on post-ESD bleeding were included. On meta-analysis, second-look endoscopy did not affect delayed post-ESD bleeding (odds ratio [95% confidence interval] = 1.27 [0.80-2.00], I2 = 0%). During second-look endoscopy, patients who were considered as high-risk for post-ESD bleeding underwent prophylactic hemostasis. Delayed post-ESD bleeding was more common in patients who were treated with hemostasis during second-look endoscopy compared with those who were not (odds ratio [95% confidence interval] = 3.40 [1.87-6.18], I2 = 62%). In patients who underwent prophylactic hemostasis, the number needed to prolong a hospitalization period to avoid one additional post-ESD bleeding after discharge was 25. CONCLUSION Second-look endoscopy after ESD could not reduce the risk of delayed post-ESD bleeding. Delayed post-ESD bleeding was more common in patients who underwent prophylactic hemostasis than in those who did not.
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Affiliation(s)
- Eun Hye Kim
- Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea
| | - Se Woo Park
- Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Guri, Gyeonggi-do, Korea
| | - Eunwoo Nam
- Biostatistics Consulting and Research Lab, Medical Research Coordinating center, Hanyang University, Seoul, Korea
| | - Chang Soo Eun
- Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Gyeonggi-do, Korea
| | - Dong Soo Han
- Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Gyeonggi-do, Korea
| | - Chan Hyuk Park
- Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Gyeonggi-do, Korea
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Kataoka Y, Tsuji Y, Sakaguchi Y, Minatsuki C, Asada-Hirayama I, Niimi K, Ono S, Kodashima S, Yamamichi N, Fujishiro M, Koike K. Bleeding after endoscopic submucosal dissection: Risk factors and preventive methods. World J Gastroenterol 2016; 22:5927-5935. [PMID: 27468187 PMCID: PMC4948274 DOI: 10.3748/wjg.v22.i26.5927] [Citation(s) in RCA: 64] [Impact Index Per Article: 7.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/11/2016] [Revised: 05/30/2016] [Accepted: 06/15/2016] [Indexed: 02/06/2023] Open
Abstract
Endoscopic submucosal dissection (ESD) has become widely accepted as a standard method of treatment for superficial gastrointestinal neoplasms because it enables en block resection even for large lesions or fibrotic lesions with minimal invasiveness, and decreases the local recurrence rate. Moreover, specimens resected in an en block fashion enable accurate histological assessment. Taking these factors into consideration, ESD seems to be more advantageous than conventional endoscopic mucosal resection (EMR), but the associated risks of perioperative adverse events are higher than in EMR. Bleeding after ESD is the most frequent among these adverse events. Although post-ESD bleeding can be controlled by endoscopic hemostasis in most cases, it may lead to serious conditions including hemorrhagic shock. Even with preventive methods including administration of acid secretion inhibitors and preventive hemostasis, post-ESD bleeding cannot be completely prevented. In addition high-risk cases for post-ESD bleeding, which include cases with the use of antithrombotic agents or which require large resection, are increasing. Although there have been many reports about associated risk factors and methods of preventing post-ESD bleeding, many issues remain unsolved. Therefore, in this review, we have overviewed risk factors and methods of preventing post-ESD bleeding from previous studies. Endoscopists should have sufficient knowledge of these risk factors and preventive methods when performing ESD.
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Uraoka T, Ochiai Y, Fujimoto A, Goto O, Kawahara Y, Kobayashi N, Kanai T, Matsuda S, Kitagawa Y, Yahagi N. A novel fully synthetic and self-assembled peptide solution for endoscopic submucosal dissection-induced ulcer in the stomach. Gastrointest Endosc 2016; 83:1259-64. [PMID: 26608126 DOI: 10.1016/j.gie.2015.11.015] [Citation(s) in RCA: 74] [Impact Index Per Article: 8.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/22/2015] [Accepted: 11/09/2015] [Indexed: 02/08/2023]
Abstract
BACKGROUND AND AIMS Endoscopic submucosal dissection (ESD) can remove early stage GI tumors of various sizes en bloc; however, success requires reducing the relatively high postprocedure bleeding rate. The aim of this study was to assess the safety and efficacy of a novel, fully synthetic, and self-assembled peptide solution that functions as an extracellular matrix scaffold material to facilitate reconstruction of normal tissues in ESD-induced ulcers. METHODS Consecutive patients who underwent gastric ESD were prospectively enrolled. Immediately after the resection, the solution was applied to the site with a catheter. Gastric ulcers were evaluated by endoscopy and classified as active, healing, or scarring stages at weeks 1, 4, and 8 after ESD. RESULTS Forty-seven patients with 53 lesions, including 14 (29.8%) previously on antithrombotic therapy and 2 (4.3%) requiring heparin bridge therapy, were analyzed; 2 patients were excluded, 1 with perforations and 1 with persistent coagulopathy. The mean size of the en bloc resected specimens was 36.5 ± 11.3 mm. The rate of post-ESD bleeding was 2.0% (1/51; 95% CI, 0.03-10.3). Transitional rate to the healing stage of ESD-induced ulcers at week 1 was 96% (49/51). Subsequent endoscopies demonstrated the scarring stage in 19% (9/48) and 98% (41/42) at weeks 4 and 8, respectively. No adverse effects related to this solution occurred. CONCLUSIONS The use of this novel peptide solution may potentially aid in reducing the delayed bleeding rate by promoting mucosal regeneration and speed of ulcer healing after large endoscopic resections in the stomach. Further studies, particularly randomized controlled studies, are needed to fully evaluate its efficacy. ( CLINICAL TRIAL REGISTRATION NUMBER 000011548.).
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Affiliation(s)
- Toshio Uraoka
- Division of Research and Development for Minimally Invasive Treatment, Cancer Center, Keio University School of Medicine, Tokyo, Japan; Department of Gastroenterology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan
| | - Yasutoshi Ochiai
- Division of Research and Development for Minimally Invasive Treatment, Cancer Center, Keio University School of Medicine, Tokyo, Japan
| | - Ai Fujimoto
- Division of Research and Development for Minimally Invasive Treatment, Cancer Center, Keio University School of Medicine, Tokyo, Japan
| | - Osamu Goto
- Division of Research and Development for Minimally Invasive Treatment, Cancer Center, Keio University School of Medicine, Tokyo, Japan
| | - Yoshiro Kawahara
- Department of Endoscopy, Okayama University Hospital, Okayama, Japan
| | | | - Takanori Kanai
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan
| | - Sachiko Matsuda
- Department of Surgery, Keio University School of Medicine, Tokyo, Japan
| | - Yuko Kitagawa
- Department of Surgery, Keio University School of Medicine, Tokyo, Japan
| | - Naohisa Yahagi
- Division of Research and Development for Minimally Invasive Treatment, Cancer Center, Keio University School of Medicine, Tokyo, Japan
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Clinical impact of second-look endoscopy after endoscopic submucosal dissection of gastric neoplasm: a multicenter prospective randomized-controlled trial. Eur J Gastroenterol Hepatol 2016; 28:546-52. [PMID: 26849462 DOI: 10.1097/meg.0000000000000586] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
OBJECTIVES This multicenter prospective randomized-controlled study was conducted to examine the effectiveness of second-look endoscopy (SLE) implemented after performing endoscopic submucosal dissection (ESD) of gastric neoplasms and to also examine which clinical and endoscopic elements are risk factors for post-ESD bleeding. PATIENTS AND METHODS Prospective randomized studies were carried out at two tertiary medical centers. Patients were divided into a group that underwent SLE (n=110) and a group that did not undergo SLE (non-SLE, n=110). The patients' clinical characteristics, endoscopic findings, and pathologic outcomes were analyzed after ESD. RESULTS The post-ESD bleeding rate was 4.1% and no difference was observed between the SLE group and the non-SLE group. There was no difference in age, sex, drug use, comorbidities, endoscopic findings, pathological findings, or ESD procedure time between the SLE group and the non-SLE group. When the 211 patients who showed no post-ESD bleeding and nine patients who showed post-ESD bleeding were compared with each other, there was no difference in whether they underwent SLE, age, drug use, comorbidities, endoscopic findings, or pathological findings. However, the risk of occurrence of post-ESD bleeding was higher when ulcers in lesions were found (odds ratio: 12.54; P=0.03). CONCLUSION The SLE group and the non-SLE group did not show any significant difference in post-ESD bleeding ratios among gastric neoplasm patients. It was shown that the risk of occurrence for post-ESD bleeding was higher in cases where there were ulcers in lesions than in cases where there was no ulcer in lesions.
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Fujishiro M, Iguchi M, Kakushima N, Kato M, Sakata Y, Hoteya S, Kataoka M, Shimaoka S, Yahagi N, Fujimoto K. Guidelines for endoscopic management of non-variceal upper gastrointestinal bleeding. Dig Endosc 2016; 28:363-378. [PMID: 26900095 DOI: 10.1111/den.12639] [Citation(s) in RCA: 60] [Impact Index Per Article: 6.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/01/2015] [Revised: 02/16/2016] [Accepted: 02/17/2016] [Indexed: 01/10/2023]
Abstract
Japan Gastroenterological Endoscopy Society (JGES) has compiled a set of guidelines for endoscopic management of non-variceal upper gastrointestinal bleeding using evidence-based methods. The major cause of non-variceal upper gastrointestinal bleeding is peptic gastroduodenal ulcer bleeding. As a result, these guidelines mainly focus on peptic gastroduodenal ulcer bleeding, although bleeding from other causes is also overviewed. From the epidemiological aspect, in recent years in Japan, bleeding from drug-related ulcers has become predominant in comparison with bleeding from Helicobacter pylori (HP)-related ulcers, owing to an increase in the aging population and coverage of HP eradication therapy by national health insurance. As for treatment, endoscopic hemostasis, in which there are a variety of methods, is considered to be the first-line treatment for bleeding from almost all causes. It is very important to precisely evaluate the severity of the patient's condition and stabilize the patient's vital signs with intensive care for successful endoscopic hemostasis. Additionally, use of antisecretory agents is recommended to prevent rebleeding after endoscopic hemostasis, especially for gastroduodenal ulcer bleeding. Eighteen statements with evidence and recommendation levels have been made by the JGES committee of these guidelines according to evidence obtained from clinical research studies. However, some of the statements that are supported by a low level of evidence must be confirmed by further clinical research.
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Affiliation(s)
| | | | | | - Motohiko Kato
- Japan Gastroenterological Endoscopy Society, Tokyo, Japan
| | | | - Shu Hoteya
- Japan Gastroenterological Endoscopy Society, Tokyo, Japan
| | | | | | - Naohisa Yahagi
- Japan Gastroenterological Endoscopy Society, Tokyo, Japan
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Shindo Y, Matsumoto S, Miyatani H, Yoshida Y, Mashima H. Risk factors for postoperative bleeding after gastric endoscopic submucosal dissection in patients under antithrombotics. World J Gastrointest Endosc 2016; 8:349-356. [PMID: 27076874 PMCID: PMC4823674 DOI: 10.4253/wjge.v8.i7.349] [Citation(s) in RCA: 27] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/29/2015] [Revised: 12/27/2015] [Accepted: 01/31/2016] [Indexed: 02/05/2023] Open
Abstract
AIM: To evaluate the risk factors for postoperative bleeding after gastric endoscopic submucosal dissection (ESD) based on the latest guidelines.
METHODS: A total of 262 gastric neoplasms were treated by ESD at our center during a 2-year period from October 2012. We analyzed the data of these cases retrospectively to identify the risk factors for post-ESD bleeding.
RESULTS: Of the 48 (18.3%) cases on antithrombotic treatment, 10 were still receiving antiplatelet drugs perioperatively, 13 were on heparin replacement after oral anticoagulant withdrawal, and the antithrombotic therapy was discontinued perioperatively in 25 cases. Postoperative bleeding occurred in 23 cases (8.8%). The postoperative bleeding rate in the heparin replacement group was 61.5%, significantly higher than that in the non-antithrombotic therapy group (6.1%). Univariate analysis identified history of antithrombotic drug use, heparin replacement, hemodialysis, cardiovascular disease, diabetes mellitus, elevated prothrombin time-international normalized ratio, and low hemoglobin level on admission as risk factors for post ESD bleeding. Multivariate analysis identified only heparin replacement (OR = 13.7, 95%CI: 1.2-151.3, P = 0.0329) as a significant risk factor for post-ESD bleeding.
CONCLUSION: Continued administration of antiplatelet agents, based on the guidelines, was not a risk factor for postoperative bleeding after gastric ESD; however, heparin replacement, which is recommended after withdrawal of oral anticoagulants, was identified as a significant risk factor.
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Ono S, Ono M, Nakagawa M, Shimizu Y, Kato M, Sakamoto N. Delayed bleeding and hemorrhage of mucosal defects after gastric endoscopic submucosal dissection on second-look endoscopy. Gastric Cancer 2016; 19:561-567. [PMID: 26089283 DOI: 10.1007/s10120-015-0507-y] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/26/2015] [Accepted: 06/06/2015] [Indexed: 02/07/2023]
Abstract
BACKGROUND Although second-look endoscopy is performed within several days after gastric endoscopic submucosal dissection (ESD), there has been no evidence supporting the usefulness of the intervention. We investigated the relationship between delayed bleeding and hemorrhage of mucosal defects after ESD on second-look endoscopy and analyzed risk factors of active bleeding on second-look endoscopy. METHODS A total of 441 consecutive ESD cases with gastric cancer or adenoma were retrospectively analyzed. Second-look endoscopy was performed in the morning after the day of ESD. Bleeding of mucosal defects on second-look endoscopy was classified according to the Forrest classification, and active bleeding was defined as Forrest Ia or Ib. Delayed bleeding was defined as hematemesis or melena after second-look endoscopy. RESULTS A total of 406 second-look endoscopies were performed, and delayed bleeding occurred in 11 patients. The incidence rate of delayed bleeding after second-look endoscopy in patients with Forrest Ia or Ib was significantly higher than that in patients with Forrest IIa, IIb or III (7.69 vs. 2.02 %, p < 0.05). Complication of a histological ulcer, large size of the resected specimen and long ESD procedure time were shown to be risk factors for hemorrhage of mucosal defects after ESD on second-look endoscopy by univariate analysis. Multivariate analysis indicated that only large size of the resected specimen was a risk factor. In a specimen size of >35 mm, the odds ratio of active bleeding on second-look endoscopy was 1.9. CONCLUSION Active bleeding of mucosal defects on second-look endoscopy is a risk factor for delayed bleeding.
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Affiliation(s)
- Shoko Ono
- Division of Endoscopy, Hokkaido University Hospital, Nishi-7, Kita-15, Kita-ku, Sapporo, 060-8638, Japan.
| | - Masayoshi Ono
- Department of Gastroenterology, Hokkaido University Graduate School of Medicine, Sapporo, Japan
| | - Manabu Nakagawa
- Division of Endoscopy, Hokkaido University Hospital, Nishi-7, Kita-15, Kita-ku, Sapporo, 060-8638, Japan
| | - Yuichi Shimizu
- Department of Gastroenterology, Hokkaido University Graduate School of Medicine, Sapporo, Japan
| | - Mototsugu Kato
- Division of Endoscopy, Hokkaido University Hospital, Nishi-7, Kita-15, Kita-ku, Sapporo, 060-8638, Japan
| | - Naoya Sakamoto
- Department of Gastroenterology, Hokkaido University Graduate School of Medicine, Sapporo, Japan
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Yoshizawa Y, Sugimoto M, Sato Y, Sahara S, Ichikawa H, Kagami T, Hosoda Y, Kimata M, Tamura S, Kobayashi Y, Osawa S, Sugimoto K, Miyajima H, Furuta T. Factors associated with healing of artificial ulcer after endoscopic submucosal dissection with reference to Helicobacter pylori infection, CYP2C19 genotype, and tumor location: Multicenter randomized trial. Dig Endosc 2016; 28:162-172. [PMID: 26331711 DOI: 10.1111/den.12544] [Citation(s) in RCA: 21] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/10/2015] [Revised: 08/27/2015] [Accepted: 08/31/2015] [Indexed: 02/06/2023]
Abstract
BACKGROUND AND AIM Healing speed of peptic ulcer is affected by a number of factors, including Helicobacter pylori (H. pylori) infection and intragastric pH. Acid inhibition exerted by proton pump inhibitors differs by CYP2C19 genotype. Herein, we investigated whether healing speed of artificial ulcers formed after endoscopic submucosal dissection (ESD) was influenced by H. pylori infection, CYP2C19 genotype, or other factors. METHODS A total of 96 H. pylori-positive patients with gastric tumors scheduled for ESD were randomly assigned to receive eradication therapy for H. pylori before ESD (pre-ESD eradication) (n = 44) or after (post-ESD eradication) (n = 52). Patients received eradication therapy consisting of lansoprazole 30 mg, amoxicillin 750 mg, and clarithromycin 200 mg twice daily for 1 week. After ESD, lansoprazole 30 mg was given once daily for 8 weeks. Ulcer size was endoscopically measured on the next day and at 4 and 8 weeks after ESD. RESULTS Mean reduction rate of artificial ulcer area in the pre-ESD eradication group was 94.7% ± 5.5% at 4 weeks, which was similar to that in the post-ESD eradication group (94.7% ± 6.7%, P = 0.987), irrespective of CYP2C19 genotype. In multivariate analyses, location of gastric tumor (middle and upper, odds ratio: 4.05, 95% CI: 1.620-10.230, P = 0.003) was a factor for 97% reduction of artificial ulcer area at 4 weeks post-ESD, but CYP2C19 genotype and H. pylori infection were not. CONCLUSION Healing speed of ESD-induced artificial ulcer was affected by tumor location, but not by time of H. pylori eradication, resected size, or CYP2C19 genotype.
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Affiliation(s)
| | | | - Yoshihiko Sato
- Department of Gastroenterology, Seirei Hamamatsu General Hospital
| | | | | | | | - Yoshisuke Hosoda
- Department of Gastroenterology, Seirei Hamamatsu General Hospital
| | - Masaharu Kimata
- Department of Gastroenterology, Seirei Hamamatsu General Hospital
| | - Satoshi Tamura
- Department of Gastroenterology, Seirei Hamamatsu General Hospital
- First Department of Medicine
| | | | | | | | | | - Takahisa Furuta
- Center for Clinical Research, Hamamatsu University of Medicine, Hamamatsu, Japan
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Kim SJ, Choi CW, Kang DH, Kim HW, Park SB. Second-look endoscopy and factors associated with delayed bleeding after endoscopic submucosal dissection. World J Gastrointest Endosc 2016; 8:173-179. [PMID: 26862367 PMCID: PMC4734976 DOI: 10.4253/wjge.v8.i3.173] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/20/2015] [Revised: 10/01/2015] [Accepted: 12/08/2015] [Indexed: 02/05/2023] Open
Abstract
Endoscopic submucosal dissection (ESD) is a widely used procedure as curative treatment for superficial gastric neoplasms, including early gastric cancer without lymph node metastasis. However, ESD requires advanced endoscopic skill and there is a major concern regarding complications from bleeding. So far, extensive efforts have been made to develop strategies to reduce post-ESD bleeding. Use of proton pump inhibitors and coagulating exposed vessels on the ulcer floor after ESD are strategies known to reduce the risk of delayed bleeding. Second-look endoscopy (SLE) is also carried out to reduce delayed bleeding following ESD in many institutions. However, the incidence of bleeding still remains around 5%, and further measures are needed to reduce delayed bleeding after gastric ESD. Recently, three randomized studies indicated that routine SLE was unnecessary. Although routine SLE may not be recommended for all patients after gastric ESD, SLE might be an important tool for the prevention of the delayed bleeding in selected high-risk patients. Thus, the identification of the risk factors, such as large size of resected specimen and treatment with multiple antiplatelet medications, may help to further guide clinicians in deciding whether to perform SLE. Studies carried out on larger cohorts are necessary to clarify the efficacy of SLE after ESD in the prevention of post-ESD bleeding in potentially high-risk patients.
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Ono H, Yao K, Fujishiro M, Oda I, Nimura S, Yahagi N, Iishi H, Oka M, Ajioka Y, Ichinose M, Matsui T. Guidelines for endoscopic submucosal dissection and endoscopic mucosal resection for early gastric cancer. Dig Endosc 2016; 28:3-15. [PMID: 26234303 DOI: 10.1111/den.12518] [Citation(s) in RCA: 402] [Impact Index Per Article: 44.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/03/2014] [Accepted: 07/29/2015] [Indexed: 12/14/2022]
Abstract
In response to the rapid and wide acceptance and use of endoscopic treatments for early gastric cancer, the Japan Gastroenterological Endoscopy Society (JGES), in collaboration with the Japanese Gastric Cancer Association (JGCA), has produced 'Guidelines for ESD and EMR for Early Gastric Cancer', as a set of basic guidelines in accordance with the principles of evidence-based medicine. These Guidelines cover the present state of knowledge and are divided into the following seven categories: Indications, Preoperative diagnosis, Techniques, Evaluation of curability, Complications, Long-term postoperative surveillance, and Histology. Twenty-three statements were finally accepted as guidelines, and the majority of these were obtained from descriptive studies with lower evidence levels. A number of statements had to be created by consensus (the lowest evidence level), as evidence levels remain low for many specific areas in this field.
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Affiliation(s)
- Hiroyuki Ono
- Japan Gastroenterological Endoscopy Society, Tokyo.,Japanese Gastric Cancer Association, Kyoto, Japan
| | - Kenshi Yao
- Japan Gastroenterological Endoscopy Society, Tokyo.,Japanese Gastric Cancer Association, Kyoto, Japan
| | - Mitsuhiro Fujishiro
- Japan Gastroenterological Endoscopy Society, Tokyo.,Japanese Gastric Cancer Association, Kyoto, Japan
| | - Ichiro Oda
- Japan Gastroenterological Endoscopy Society, Tokyo.,Japanese Gastric Cancer Association, Kyoto, Japan
| | | | - Naohisa Yahagi
- Japan Gastroenterological Endoscopy Society, Tokyo.,Japanese Gastric Cancer Association, Kyoto, Japan
| | - Hiroyasu Iishi
- Japan Gastroenterological Endoscopy Society, Tokyo.,Japanese Gastric Cancer Association, Kyoto, Japan
| | - Masashi Oka
- Japan Gastroenterological Endoscopy Society, Tokyo.,Japanese Gastric Cancer Association, Kyoto, Japan
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Jung JH, Kim BJ, Choi CH, Kim JG. Second-look endoscopy with prophylactic hemostasis is still effective after endoscopic submucosal dissection for gastric neoplasm. World J Gastroenterol 2015; 21:13518-13523. [PMID: 26730163 PMCID: PMC4690181 DOI: 10.3748/wjg.v21.i48.13518] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/30/2015] [Revised: 11/19/2015] [Accepted: 12/14/2015] [Indexed: 02/07/2023] Open
Abstract
AIM: The clinical value of second-look endoscopy (SLE) after endoscopic submucosal dissection (ESD) has been doubted continuously. The aim of this study was to assess the effectiveness of SLE based on the risk of delayed bleeding after ESD.
METHODS: A total of 310 lesions of gastric epithelial neoplasms treated by ESD were reviewed. The lesions were divided into two groups based on the risk of post-procedural bleeding estimated by Forrest classification. The high risk of rebleeding group (Forrest Ia, Ib and IIa) required endoscopic treatment, while the low risk of rebleeding group (Forrest IIb, IIc and III) did not. Delayed bleeding after ESD was investigated.
RESULTS: Sixty-six lesions were included in the high risk of rebleeding group and 244 lesions in the low risk of rebleeding group. There were no significant differences in delayed bleeding between the high risk group (1/66) and the low risk group (1/244) (P = 0.38). The high risk of rebleeding group tended to be located more often in the mid-third and had higher appearance of flat or depressed shape than the low risk group (P = 0.004 and P = 0.006, respectively).
CONCLUSION: SLE with pre-emptive prophylactic endoscopic treatment is still effective in preventing delayed bleeding after ESD.
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Song WC, Qiao XL, Gao XZ. A comparison of endoscopic submucosal dissection (ESD) and radical surgery for early gastric cancer: a retrospective study. World J Surg Oncol 2015; 13:309. [PMID: 26537433 PMCID: PMC4634741 DOI: 10.1186/s12957-015-0724-1] [Citation(s) in RCA: 27] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/09/2015] [Accepted: 10/26/2015] [Indexed: 02/06/2023] Open
Abstract
Background Endoscopic submucosal dissection (ESD) has become one of the mainstays of treatment for early gastric cancer (EGC). Radical surgery is also a classical treatment method for EGC. There have been no systematic clinical studies of the curative effects and adverse events associated with ESD vs. radical surgery for EGC. This study investigated the therapeutic efficacy and safety of ESD and radical surgery for EGC. Methods Twenty-nine patients with EGC underwent ESD, and 59 underwent radical surgery at Weihai Municipal Hospital. The pathological characteristics, postoperative outcomes, hospital course, morbidity and mortality were retrospectively compared between the two groups. Results The oncological clearance was 93.1 % (27/29) in the ESD group. Postoperative delayed haemorrhage occurred in two patients. The hospital stay ranged from 10 to 23 days, and the average stay was 14.3 ± 3.7 days. The patients were followed-up for 1 to 5 years, with a mean follow-up of 26.9 ± 8.5 months. Regular endoscopic examinations showed that the wound had healed with no cancer recurrence in all of the patients. In the radical surgery group, the oncological clearance was 100 % (59/59). The hospital stay ranged from 11 to 55 days, and the average stay was 21.7 ± 9.3 days. The patients were followed-up for 1 to 3.7 years, with a mean follow-up of 22.3 ± 9.4 months. Nine patients developed complications, including acute postoperative adhesive ileus (1/59) and symptomatic residual gastritis (3/59). These complications were improved by an additional operation, drainage, gastrointestinal decompression and comprehensive therapy. Conclusions ESD achieved similar efficacy and had many advantages compared with radical surgery for the treatment of EGC.
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Affiliation(s)
- Wen-Chong Song
- Gastroenterology Division, Weihai Municipal Hospital, Weihai, 264200, People's Republic of China.
| | - Xiu-Li Qiao
- Gastroenterology Division, Weihai Municipal Hospital, Weihai, 264200, People's Republic of China.
| | - Xiao-Zhong Gao
- Gastroenterology Division, Weihai Municipal Hospital, Weihai, 264200, People's Republic of China.
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Zhang Y, Huang L, Li L, Ji F. Endoscopic submucosal dissection for early gastric neoplasms in elderly patients. J Laparoendosc Adv Surg Tech A 2015; 24:391-8. [PMID: 24914925 DOI: 10.1089/lap.2013.0572] [Citation(s) in RCA: 19] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
OBJECTIVE To retrospectively evaluate the safety and feasibility of endoscopic submucosal dissection (ESD) for the treatment of early gastric cancer (EGC) in elderly patients ≥75 years of age. PATIENTS AND METHODS One hundred seventy-one patients (187 lesions) treated with ESD from January 2010 to September 2013 were enrolled in our study. Subjects were classified into two groups: elderly (age ≥75 years) or non-elderly (age <75 years). Clinicopathological characteristics, resectability, curability, complications, rates of local recurrence, and residual disease were evaluated. Association of clinicopathological characteristics of the lesions with immediate bleeding was analyzed. RESULTS No significant differences in clinical characteristics were observed. The incidences of comorbidity were significantly different between the elderly group and the non-elderly group (P<.001). Of the elderly patients, 54.3% had two or more underlying diseases compared with 18.4% of the non-elderly patients (P<.001). Of the 98.0% of elderly patients and 97.1% of younger patients who received en bloc resection, curative resection reached 94.1% and 96.3%, respectively. Immediate bleeding occurred in 15.2% of the elderly group and 4.8% of the non-elderly group (P=.044). Operation time differed significantly (P=.039). No apparent discrepancy was observed in perforation and delayed bleeding. The differences in the invasion depth were considered between the two groups (P=.001). Logistic regression analysis revealed that the rate of immediate bleeding was associated with invasion depth (P=.003). There were no differences in the follow-up period and rates of local recurrence and residual disease. CONCLUSIONS ESD is safe and feasible for elderly patients in the era of a graying population. Higher risk of immediate bleeding and longer operation time should be concerned.
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Affiliation(s)
- Yan Zhang
- 1 Department of Gastroenterology, The First Affiliated Hospital, College of Medicine, Zhejiang University , Hangzhou, China
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Tsuji Y, Fujishiro M, Kodashima S, Ono S, Niimi K, Mochizuki S, Asada-Hirayama I, Matsuda R, Minatsuki C, Nakayama C, Takahashi Y, Sakaguchi Y, Yamamichi N, Koike K. Polyglycolic acid sheets and fibrin glue decrease the risk of bleeding after endoscopic submucosal dissection of gastric neoplasms (with video). Gastrointest Endosc 2015; 81:906-912. [PMID: 25440679 DOI: 10.1016/j.gie.2014.08.028] [Citation(s) in RCA: 76] [Impact Index Per Article: 7.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/10/2014] [Accepted: 08/25/2014] [Indexed: 12/17/2022]
Abstract
BACKGROUND The prevention of bleeding after endoscopic submucosal dissection (ESD) for gastric neoplasms is still an important problem. OBJECTIVE To investigate the efficacy and safety of a shielding method that uses polyglycolic acid (PGA) sheets and fibrin glue to prevent post-ESD bleeding in high-risk patients. DESIGN A nonrandomized trial with historical control subjects. SETTING A single academic hospital in Japan. PATIENTS From July 2013 to February 2014, 45 ESD-induced ulcers in 41 patients with a high risk of bleeding were enrolled in a study group. Forty-one consecutive ESD-induced ulcers in 37 control subjects with a high risk of bleeding were treated in 2013 before the first enrollment. INTERVENTIONS We placed PGA sheets on the mucosal defect and fixed with fibrin glue in the study group. MAIN OUTCOME MEASUREMENTS The post-ESD bleeding rate. RESULTS The post-ESD bleeding occurred at a rate of 6.7% in the study group (3/45 lesions) and 22.0% in the historical control group (9/41 lesions). There was a significant difference in the post-ESD bleeding rate between the 2 groups (P = .041). LIMITATIONS A nonrandomized trial with historical control subjects; a single-center analysis; small sample size. CONCLUSIONS The endoscopic tissue shielding method with PGA sheets and fibrin glue appears to be promising for the prevention of post-ESD bleeding. ( CLINICAL TRIAL REGISTRATION NUMBER UMIN000011058.).
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Affiliation(s)
- Yosuke Tsuji
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Mitsuhiro Fujishiro
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Shinya Kodashima
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Satoshi Ono
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Keiko Niimi
- Center for Epidemiology and Preventive Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Satoshi Mochizuki
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Itsuko Asada-Hirayama
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Rie Matsuda
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Chihiro Minatsuki
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Chiemi Nakayama
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Yu Takahashi
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Yoshiki Sakaguchi
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Nobutake Yamamichi
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Kazuhiko Koike
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
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Mochizuki S, Uedo N, Oda I, Kaneko K, Yamamoto Y, Yamashina T, Suzuki H, Kodashima S, Yano T, Yamamichi N, Goto O, Shimamoto T, Fujishiro M, Koike K. Scheduled second-look endoscopy is not recommended after endoscopic submucosal dissection for gastric neoplasms (the SAFE trial): a multicentre prospective randomised controlled non-inferiority trial. Gut 2015; 64:397-405. [PMID: 25301853 DOI: 10.1136/gutjnl-2014-307552] [Citation(s) in RCA: 81] [Impact Index Per Article: 8.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
OBJECTIVE To clarify the effectiveness of second-look endoscopy (SLE) at preventing bleeding after gastric endoscopic submucosal dissection (ESD). DESIGN A multicentre prospective randomised controlled non-inferiority trial was conducted at five referral institutions across Japan. Patients with a solitary gastric neoplasm were enrolled. Exclusion criteria were previous oesophagogastric surgery or radiation therapy; perforation and the administration of antithrombotics, steroids or non-steroidal anti-inflammatory drugs. Patients were assigned to the SLE group or the non-SLE group by a computer-generated random sequence after ESD and were treated perioperatively with a proton pump inhibitor. SLE was performed one day after ESD. The primary endpoint was post-ESD bleeding, defined as an endoscopically proven haemorrhage. The trial had the power to detect a non-inferiority criterion of 7% between the groups. RESULTS From February 2012 to February 2013, 130 and 132 patients were assigned to the SLE and the non-SLE groups, respectively. All patients were included in the intention-to-treat analysis of the primary endpoint. Post-ESD bleeding occurred in seven patients with (5.4%) SLE and five patients with (3.8%) non-SLE (risk difference--1.6% (95% CI -6.7 to 3.5); pnon-inferiority<0.001), meeting the non-inferiority criterion. All 12 patients with post-ESD bleeding and one patient with a delayed perforation were successfully managed with conservative treatment. CONCLUSIONS SLE after gastric ESD is not routinely recommended because it does not contribute to the prevention of post-ESD bleeding for patients with an average bleeding risk. TRIAL REGISTRATION NUMBER UMIN-CTR000007170.
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Affiliation(s)
- Satoshi Mochizuki
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Noriya Uedo
- Department of Gastrointestinal Oncology, Osaka Medical Centre for Cancer and Cardiovascular Diseases, Osaka, Japan
| | - Ichiro Oda
- Endoscopy Division, National Cancer Centre Hospital, Tokyo, Japan
| | - Kazuhiro Kaneko
- Department of Gastroenterology, Endoscopy division, National Cancer Centre Hospital East, Kashiwa, Japan
| | - Yorimasa Yamamoto
- Endoscopy Division, Gastrointestinal Centre, Cancer Institute Hospital, Tokyo, Japan
| | - Takeshi Yamashina
- Department of Gastrointestinal Oncology, Osaka Medical Centre for Cancer and Cardiovascular Diseases, Osaka, Japan
| | - Haruhisa Suzuki
- Endoscopy Division, National Cancer Centre Hospital, Tokyo, Japan
| | - Shinya Kodashima
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Tomonori Yano
- Department of Gastroenterology, Endoscopy division, National Cancer Centre Hospital East, Kashiwa, Japan
| | - Nobutake Yamamichi
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Osamu Goto
- Division of Research and Development for Minimally Invasive Treatment, Cancer Centre, School of Medicine, Keio University, Tokyo, Japan
| | - Takeshi Shimamoto
- Department of Statistics and Information Management, Kameda Medical Centre Makuhari, Chiba, Japan
| | - Mitsuhiro Fujishiro
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Kazuhiko Koike
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
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Nishizawa T, Suzuki H, Kinoshita S, Goto O, Kanai T, Yahagi N. Second-look endoscopy after endoscopic submucosal dissection for gastric neoplasms. Dig Endosc 2015; 27:279-84. [PMID: 25423881 DOI: 10.1111/den.12410] [Citation(s) in RCA: 21] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/22/2014] [Accepted: 11/21/2014] [Indexed: 02/06/2023]
Abstract
Routine second-look endoscopy after gastric endoscopic submucosal dissection (ESD) remains controversial. The aim of the present study was to systematically evaluate the efficacy of second-look endoscopy for gastric ESD. PubMed, the Cochrane library, and the Igaku-chuo-zasshi database were searched in order to identify randomized trials eligible for inclusion in the systematic review. Data were combined to calculate a pooled odds ratio (OR) for developing post-ESD bleeding. The database search yielded three randomized trials (854 patients). Compared with second-look endoscopy, the pooled OR for post-ESD bleeding without second-look endoscopy was 0.69 (95% confidence interval [CI]: 0.38-1.26, P = 0.228), without significant heterogeneity. There were no significant differences between second-look endoscopy and no second-look endoscopy with regard to large tumor size (>20 mm). This systematic review and meta-analysis showed that second-look endoscopy had no advantage for the prevention of post-ESD bleeding in patients without a high risk of bleeding.
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Affiliation(s)
- Toshihiro Nishizawa
- Division of Research and Development for Minimally Invasive Treatment, Cancer Center, Keio University School of Medicine, Tokyo, Japan; Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan
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