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1
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Takeda T, Sasaki T, Okamoto T, Mie T, Sato Y, Maegawa Y, Hirai T, Suzuki Y, Furukawa T, Ozaka M, Sasahira N. Outcomes of multi-hole self-expandable metal stents versus fully covered self-expandable metal stents for malignant distal biliary obstruction in unresectable pancreatic cancer. DEN OPEN 2025; 5:e70014. [PMID: 39323619 PMCID: PMC11422663 DOI: 10.1002/deo2.70014] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 08/01/2024] [Revised: 08/29/2024] [Accepted: 09/05/2024] [Indexed: 09/27/2024]
Abstract
Objectives The multi-hole self-expandable metal stent (MHSEMS) is a novel SEMS with multiple small side holes on the covering membrane to prevent stent migration while minimizing tumor ingrowth. This study aimed to evaluate the clinical outcomes of MHSEMS in comparison with conventional covered SEMS (c-CMS). Methods Consecutive patients with unresectable pancreatic cancer who underwent initial SEMS placement (MHSEMS or c-CMS) for malignant distal biliary obstruction were analyzed. Technical success, clinical success, causes of recurrent biliary obstruction (RBO), non-RBO adverse events, time to RBO (TRBO), and endoscopic reintervention were compared between groups. Results A total of 65 patients were included (MHSEMS: 27, c-CMS: 38). The technical success, clinical success, and non-RBO adverse event rates were similar between groups. Although stent migration was less frequently observed in the MHSEMS group (0% vs. 17.6%, p = 0.032), overall RBO rates were similar between groups (53.8% vs. 55.9%, p > 0.99). The most common cause of RBO within 14 days in the MHSEMS group was non-occlusion cholangitis. Median TRBO was significantly shorter in the MHSEMS group (101 vs. 227 days, p = 0.030) and MHSEMS was an independent predictor for shorter TRBO in multivariate analysis (hazard ratio, 2.27; 95% confidence interval, 1.06-4.86; p = 0.034). Outcomes after endoscopic interventio were not significantly different between groups. Stent removal was successful in all attempted cases in both groups. Conclusions MHSEMS was associated with a significantly shorter TRBO compared to c-CMS. Further modifications of the present MHSEMS may be needed.
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Affiliation(s)
- Tsuyoshi Takeda
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Takashi Sasaki
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Takeshi Okamoto
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Takafumi Mie
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Yoichiro Sato
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Yuri Maegawa
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Tatsuki Hirai
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Yukari Suzuki
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Takaaki Furukawa
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Masato Ozaka
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Naoki Sasahira
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
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Kohashi S, Sakai A, Furumatsu K, Ezaki T, Iemoto T, Tanaka T, Tsujimae M, Kobayashi T, Masuda A, Kodama Y. The anti-migration effect of partially covered self-expandable metal stents for unresectable malignant distal biliary obstruction: A multicenter comparative study. DEN OPEN 2025; 5:e70100. [PMID: 40115595 PMCID: PMC11923903 DOI: 10.1002/deo2.70100] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 01/17/2025] [Revised: 02/26/2025] [Accepted: 03/10/2025] [Indexed: 03/23/2025]
Abstract
Objectives Covered self-expandable metal stents are commonly used for unresectable malignant distal biliary obstruction. Partially covered self-expandable metal stents have uncovered sections at both ends; however, their anti-migration effect remains unclear. The objective of this study was to evaluate that effect by comparing such stents with fully covered self-expandable metal stents for patients with unresectable malignant distal biliary obstruction. Methods This was a multicenter, retrospective comparative study of partially covered stents with fully covered stents for unresectable malignant distal biliary obstruction. Stent migration, recurrent biliary obstruction, and the time to recurrent biliary obstruction were compared between them. Results Thirty-nine patients with partially covered stents were included and compared with 42 patients with fully covered stents. The partially covered group had a significantly lower stent migration rate (3% vs. 36%; p < 0.001). The recurrent biliary obstruction rate was significantly lower in the partially covered group (21% vs. 43%; p = 0.036). The non-recurrent biliary obstruction rate at 6 months was 90% and 68% in the partially and fully covered groups, respectively. The time to recurrent biliary obstruction was significantly longer in the partially covered group (Gray's test, p = 0.016). Only partially covered stent placement was significantly associated with a lower risk of stent migration (subdistribution hazard ratio = 0.077; 95% confidence interval = 0.01-0.60; p = 0.014) in the multivariable analysis. Conclusions The anti-migration effect of partially covered self-expandable metal stents was associated with a reduced recurrence of biliary obstruction and prolonged time to such obstruction.
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Affiliation(s)
- Shinya Kohashi
- Department of Internal Medicine Division of Gastroenterology Kobe University Graduate School of Medicine Hyogo Japan
| | - Arata Sakai
- Department of Internal Medicine Division of Gastroenterology Kobe University Graduate School of Medicine Hyogo Japan
| | - Keisuke Furumatsu
- Department of Gastroenterology Akashi Medical Center Hyogo Japan
- Department of Gastroenterology Osaka Saiseikai Nakatsu Hospital Osaka Japan
| | - Takeshi Ezaki
- Department of Gastroenterology Kobe Medical Center Hyogo Japan
| | - Takao Iemoto
- Department of Gastroenterology Kita-harima Medical Center Hyogo Japan
| | - Takeshi Tanaka
- Department of Internal Medicine Division of Gastroenterology Kobe University Graduate School of Medicine Hyogo Japan
| | - Masahiro Tsujimae
- Department of Internal Medicine Division of Gastroenterology Kobe University Graduate School of Medicine Hyogo Japan
| | - Takashi Kobayashi
- Department of Internal Medicine Division of Gastroenterology Kobe University Graduate School of Medicine Hyogo Japan
| | - Atsuhiro Masuda
- Department of Internal Medicine Division of Gastroenterology Kobe University Graduate School of Medicine Hyogo Japan
| | - Yuzo Kodama
- Department of Internal Medicine Division of Gastroenterology Kobe University Graduate School of Medicine Hyogo Japan
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Koga T, Yamada H, Ishida Y, Tsuchiya N, Kitaguchi T, Matsumoto K, Fukuyama M, Kojima N, Hirai F. Radial force and wire structure determine the onset of covered self-expandable metal stent migration in endoscopic ultrasound-guided hepaticogastrostomy: Measurement of sliding-resistance force using a porcine model. JOURNAL OF HEPATO-BILIARY-PANCREATIC SCIENCES 2024; 31:840-849. [PMID: 39075945 DOI: 10.1002/jhbp.12050] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 07/31/2024]
Abstract
BACKGROUND Self-expandable metal stent (SEMS) migration after endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) is a severe complication. The migration risk could be related to the surface friction of SEMS, assumed to be affected by the wire structure and mechanical properties, including radial force (RF); however, their relevance remains unclear. This experimental study aimed to assess the mechanical properties of SEMS involved in the onset of stent migration by measuring the sliding-resistance force (SF) as the SEMS moves through the stomach wall. METHODS The SF of seven types of 8-mm diameter SEMS (four braided and three laser-cut types) and porcine stomach wall was measured with a universal testing machine. The SF of each SEMS was measured three times, and the average maximum SF (SFmax) was used for analysis. The correlation between SFmax and RF of each SEMS was evaluated. RESULTS SFmax and RF showed a very strong positive correlation (r = 0.92). Compared to the regression line predictions in the scatter plots of SFmax and RF, the SFmax of laser-cut and braided type SEMSs had positive and negative residuals, respectively. CONCLUSIONS Selecting a laser-cut type SEMS with a higher RF may more effectively prevent the onset of stent migration against the stomach wall in EUS-HGS.
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Affiliation(s)
- Takehiko Koga
- Department of Gastroenterology and Medicine, Fukuoka University Faculty of Medicine, Fukuoka, Japan
| | - Hiroshi Yamada
- Department of Biological Functions Engineering, Graduate School of Life Science and Systems Engineering, Kyushu Institute of Technology, Kitakyushu, Japan
| | - Yusuke Ishida
- Department of Gastroenterology and Medicine, Fukuoka University Faculty of Medicine, Fukuoka, Japan
| | - Naoaki Tsuchiya
- Department of Gastroenterology and Medicine, Fukuoka University Faculty of Medicine, Fukuoka, Japan
| | - Takanori Kitaguchi
- Department of Gastroenterology and Medicine, Fukuoka University Faculty of Medicine, Fukuoka, Japan
| | - Keisuke Matsumoto
- Department of Gastroenterology and Medicine, Fukuoka University Faculty of Medicine, Fukuoka, Japan
| | - Makoto Fukuyama
- Department of Gastroenterology and Medicine, Fukuoka University Faculty of Medicine, Fukuoka, Japan
| | - Norihiro Kojima
- Department of Gastroenterology, Taragi Municipal Hospital, Kumamoto, Japan
| | - Fumihito Hirai
- Department of Gastroenterology and Medicine, Fukuoka University Faculty of Medicine, Fukuoka, Japan
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Hasegawa S, Sato T, Shinoda S, Kurita Y, Ogata T, Nihei S, Yagi S, Hosono K, Endo I, Kobayashi N, Kubota K, Nakajima A. Braided-type stent versus laser-cut-type stent for patients with unresectable distal malignant biliary obstruction: a randomized controlled trial. Gastrointest Endosc 2024; 99:739-746.e1. [PMID: 38065510 DOI: 10.1016/j.gie.2023.11.057] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/20/2023] [Revised: 10/18/2023] [Accepted: 11/26/2023] [Indexed: 03/24/2024]
Abstract
BACKGROUND AND AIMS Fully covered self-expandable metallic stents (SEMSs) are laser-cut (L) or braided (B); however, it remains unclear which approach is more effective for distal malignant biliary obstruction (DMBO). This study compared the clinical outcomes of using L-type and B-type stents because we believe that recurrent biliary obstruction (RBO) is less likely to occur with L-type stents. METHODS Patients diagnosed with unresectable DMBO were randomly assigned to groups L and B in a stratified block fashion, and outcomes were compared. The primary outcome was the rate of RBO within 1 year; secondary outcomes were adverse events, clinical success rate, time to RBO (TRBO), and overall survival. RESULTS Of the 60 enrolled participants, 56 (group L, n = 27; group B, n = 29) were included. The rates of RBO within 1 year were 44.4% and 17.2% in groups L and B, respectively (odds ratio, 2.57; 95% confidence interval [CI], 1.045-6.353). Early adverse events, which improved with conservative treatment, included pancreatitis (n = 4) in group L and pancreatitis (n = 3) and cholecystitis (n = 1) in group B (P = .913). The median TRBO (220 days [95% CI, 56-272] vs 418 days [95% CI, 232-454]) was significantly longer in group B than in group L (log-rank test, P = .0118). The median overall survival (group L, 158 days; group B, 204 days) after stenting was not significantly different between groups (P = .8544). CONCLUSIONS In the setting of DMBO, B-type stents are associated with less recurrent obstruction than L-type stents, although there was no difference in safety. (UMIN Clinical Trials Registry number: UMIN000027239.).
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Affiliation(s)
- Sho Hasegawa
- Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine Graduate School of Medicine, Yokohama, Japan.
| | - Takamitsu Sato
- Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine Graduate School of Medicine, Yokohama, Japan
| | - Satoru Shinoda
- Department of Biostatistics, Yokohama City University School of Medicine Graduate School of Medicine, Yokohama, Japan
| | - Yusuke Kurita
- Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine Graduate School of Medicine, Yokohama, Japan
| | - Tomoki Ogata
- Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine Graduate School of Medicine, Yokohama, Japan
| | - Shinichi Nihei
- Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine Graduate School of Medicine, Yokohama, Japan
| | - Shin Yagi
- Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine Graduate School of Medicine, Yokohama, Japan
| | - Kunihiro Hosono
- Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine Graduate School of Medicine, Yokohama, Japan
| | - Itaru Endo
- Department of Gastroenterological Surgery, Yokohama City University School of Medicine Graduate School of Medicine, Yokohama, Japan
| | - Noritoshi Kobayashi
- Department of Oncology, Yokohama City University School of Medicine Graduate School of Medicine, Yokohama, Japan
| | - Kensuke Kubota
- Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine Graduate School of Medicine, Yokohama, Japan
| | - Atsushi Nakajima
- Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine Graduate School of Medicine, Yokohama, Japan
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Kulpatcharapong S, Piyachaturawat P, Mekaroonkamol P, Angsuwatcharakon P, Ridtitid W, Kongkam P, Rerknimitr R. Efficacy of multi-hole self-expandable metal stent compared to fully covered and uncovered self-expandable metal stents in patients with unresectable malignant distal biliary obstruction: a propensity analysis. Surg Endosc 2024; 38:212-221. [PMID: 37964091 DOI: 10.1007/s00464-023-10541-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/01/2023] [Accepted: 10/12/2023] [Indexed: 11/16/2023]
Abstract
BACKGROUND AND AIMS Self-expandable metal stent (SEMS) insertion is the standard palliative treatment for unresectable malignant extrahepatic biliary obstruction (MBO). Drawbacks of conventional fully covered SEMS (FCSEMS) and uncovered SEMS (USEMS) include stent migration and tumor ingrowth, respectively. This study aimed to compare stent patency in MBO with the newly design multi-hole SEMS (MHSEMS), which has multiple small side holes in the stent membrane, with conventional FCSEMS and UCSEMS. PATIENTS AND METHODS This retrospective study using a propensity score matching design and stent patency times of 40 patients with MHSEMS was compared to 40 and 34 patients with FCSEMS and UCSEMS during the same period, respectively. Secondary outcomes were procedure-related adverse events, clinical success rate, time to recurrent biliary obstruction (RBO), and etiology of RBO. RBO was compared using Kaplan-Meier analysis. RESULTS Baseline characteristics after matching were comparable among the 3 groups. RBO rates were 21%, 37%, and 55% for MHSEMS, FCSEMS, and UCSEMS, respectively (p = 0.014), at a mean time of 479, 353, and 306 days, respectively (MHSEMS vs UCSEMS, p = 0.002). Rate of tumor ingrowth was highest in the UCSEMS group (42.4% vs 13.2% in MHSEMS; p = 0.005 and vs 0% in FCSEMS; p < 0.001). Stent migration rate was highest in the FCSEMS group at 15.8% vs 2.6% in MHSEMS (p = 0.047) and 0% in UCSEMS (p = 0.005). CONCLUSION MHSEMS provided the longest stent patency time with lowest RBO rate compared to conventional SEMS by showing a lower stent migration rate than FCSEMS and a lower tumor ingrowth rate than UCSEMS.
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Affiliation(s)
- Santi Kulpatcharapong
- Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Thai Red Cross Society, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Rama 4 Road, Patumwan, Bangkok, 10330, Thailand
| | - Panida Piyachaturawat
- Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Thai Red Cross Society, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Rama 4 Road, Patumwan, Bangkok, 10330, Thailand
| | - Parit Mekaroonkamol
- Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Thai Red Cross Society, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Rama 4 Road, Patumwan, Bangkok, 10330, Thailand
| | - Phonthep Angsuwatcharakon
- Department of Anatomy, Faculty of Medicine, Thai Red Cross Society, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand
| | - Wiriyaporn Ridtitid
- Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Thai Red Cross Society, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Rama 4 Road, Patumwan, Bangkok, 10330, Thailand
| | - Pradermchai Kongkam
- Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Thai Red Cross Society, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Rama 4 Road, Patumwan, Bangkok, 10330, Thailand
| | - Rungsun Rerknimitr
- Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Thai Red Cross Society, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Rama 4 Road, Patumwan, Bangkok, 10330, Thailand.
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6
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Loganathan P, Chandan S, Mohan BP, Saligram S, Adler DG. Comparable Efficacy of Laser-Cut and Braided Self Expanding Metallic Biliary Stent: A Systematic Review and Meta-Analysis. Dig Dis Sci 2023; 68:3756-3764. [PMID: 37439926 DOI: 10.1007/s10620-023-08017-w] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/10/2023] [Accepted: 06/18/2023] [Indexed: 07/14/2023]
Abstract
BACKGROUND AND AIMS In patients with unresectable malignant biliary obstruction (MBO), endoscopic biliary drainage is the treatment of choice. Self-expanding metallic stents (SEMS) are mainly used for this purpose, and data is limited on the comparative outcomes of laser-cut versus braided SEMS. Herein, we performed the first systematic review and meta-analysis to study the effectiveness and safety of braided and laser-cut SEMS in MBO. METHODS Multiple databases, including Medline, Scopus, and Embase, were searched (in May 2022) using specific terms for studies evaluating the outcomes of braided and laser-cut SEMS in MBO. Outcomes of interest were technical and clinical success, recurrent biliary obstruction, and adverse events. Standard meta-analysis methods were employed using the random-effects model. I2% heterogeneity was used to assess the heterogeneity. RESULTS Seven studies were included in the final analysis. (Laser-cut: 271 patients, 46% females, mean age 70 years; and braided: 282 patients, 47% females, mean age 72 years). The pooled rate of technical success and clinical success with laser-cut SEMS was 99% (95% CI [95-99; I2 = 0%]), 86% [60-96; I2 = 74%], and 98% [96-99; I2 = 0%], 89% [74-95; I2 = 78%] with braided. The pooled rate of recurrent biliary obstruction with laser-cut SEMS was 26% [14-43; I2 = 88%] and 12% [5-27; I2 = 56%) with braided. Pooled total adverse events were 11% [5-21; I2 = 77%] in laser-cut and 12% [6-24; I2 = 63%] in braided. CONCLUSION Our meta-analysis demonstrates similar clinical outcomes with laser-cut and braided SEMS in MBO. Given the comparable performance, a cost-effectiveness analysis might help in choosing one type versus another in patients with MBO.
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Affiliation(s)
| | | | - Babu P Mohan
- Gastroenterology & Hepatology, University of Utah Health, Salt Lake City, UT, USA
| | - Shreyas Saligram
- Gastroenterology, University of Texas Health Science Center, San Antonio, TX, USA
| | - Douglas G Adler
- Gastroenterology, Center for Advanced Therapeutic Endoscopy, Centura Health, Denver, CO, USA.
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Gu J, Guo X, Sun Y, Fan B, Li H, Luo T, Luo H, Liu J, Gao F, Gao Y, Tan G, Liu X, Yang Z. Efficacy and complications of inoperable malignant distal biliary obstruction treatment by metallic stents: fully covered or uncovered? Gastroenterol Rep (Oxf) 2023; 11:goad048. [PMID: 37622087 PMCID: PMC10444961 DOI: 10.1093/gastro/goad048] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/22/2022] [Revised: 07/09/2023] [Accepted: 07/30/2023] [Indexed: 08/26/2023] Open
Abstract
Obstructive jaundice caused by malignant distal biliary obstruction is a common clinical symptom in patients with inoperable biliary-pancreatic cancer. Endoscopic retrograde cholangiopancreatography (ERCP)-guided stent implantation is an effective treatment for obstructive jaundice. Internal stent drainage is more physiologic and associated with a better quality of life than external stent drainage methods such as percutaneous transhepatic gallbladder drainage or percutaneous transhepatic cholangiodrainage. Self-expanding metallic stents, which may be covered and uncovered, are commonly used. However, some uncertainties remain regarding the selection of metallic stents, including drainage patency time, clinical effect, stent migration, and post-operative complications such as pancreatitis, bleeding, and cholecystitis. This review aims to summarize the current progress and controversies surrounding the use of covered or uncovered metallic stents in inoperable common biliary obstruction via ERCP.
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Affiliation(s)
- Jiangning Gu
- Department of Endoscope, General Hospital of Northern Theater Command, Shenyang, Liaoning, P. R. China
- Department of Hepatobiliary Surgery, The First affiliated Hospital of Dalian Medical University, Dalian, Liaoning, P. R. China
| | - Xiaoyi Guo
- Department of Hepatobiliary Surgery, The First affiliated Hospital of Dalian Medical University, Dalian, Liaoning, P. R. China
| | - Yong Sun
- Department of Endoscope, General Hospital of Northern Theater Command, Shenyang, Liaoning, P. R. China
| | - Bin Fan
- Department of General Surgery, The First Hospital of Northwest University (Xi'an No. 1 Hospital), Xi'an, Shaanxi, P. R. China
| | - Haoran Li
- Department of Endoscope, General Hospital of Northern Theater Command, Shenyang, Liaoning, P. R. China
| | - Ting Luo
- Department of Endoscope, General Hospital of Northern Theater Command, Shenyang, Liaoning, P. R. China
| | - Haifeng Luo
- Department of Hepatobiliary Surgery, The First affiliated Hospital of Dalian Medical University, Dalian, Liaoning, P. R. China
| | - Jiao Liu
- Department of Endoscope, General Hospital of Northern Theater Command, Shenyang, Liaoning, P. R. China
| | - Feng Gao
- Department of Endoscope, General Hospital of Northern Theater Command, Shenyang, Liaoning, P. R. China
| | - Yuan Gao
- Department of Endoscope, General Hospital of Northern Theater Command, Shenyang, Liaoning, P. R. China
| | - Guang Tan
- Department of Hepatobiliary Surgery, The First affiliated Hospital of Dalian Medical University, Dalian, Liaoning, P. R. China
| | - Xiaoming Liu
- Department of Anesthesiology, The First affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China
| | - Zhuo Yang
- Department of Endoscope, General Hospital of Northern Theater Command, Shenyang, Liaoning, P. R. China
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Yamada Y, Sasaki T, Takeda T, Okamoto T, Mie T, Yonekura C, Furukawa T, Kasuga A, Matsuyama M, Ozaka M, Matsuda T, Igarashi Y, Sasahira N. Removal of Duckbill-type laser-cut anti-reflux metal stents: Clinical evaluation and in vitro study. DEN OPEN 2023; 3:e217. [PMID: 36843624 PMCID: PMC9950539 DOI: 10.1002/deo2.217] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 12/20/2022] [Revised: 02/01/2023] [Accepted: 02/06/2023] [Indexed: 02/26/2023]
Abstract
Objectives Duckbill-type metal stent (DMS) was the first laser-cut biliary metal stent with an anti-reflux valve. Removal of DMS is believed to be difficult and relevant reports are scarce. This study aims to investigate the feasibility of DMS removal. Methods We retrospectively analyzed patients who underwent DMS removal between June 2019 and March 2022 to evaluate success rates and factors affecting outcomes. In addition, six different methods of DMS removal were reproduced in vitro, varying removal devices, angle of applied force, and grasped location. Extraction resistance, the distance of forceps stroke, and stent length after removal were compared. Results Forty patients were enrolled, and DMS removal was successful in 31 cases (78%). No adverse events were observed. Tumor ingrowth was evident in 78% (7/9) of failed cases. Patients receiving biliary metal stents for the first time (naïve cases), long indwelling time, longer stent, and stent tearing during removal were associated with unsuccessful stent removal. In the in vitro study, a larger force was required to remove the stent at an extraction angle of 120° than at 0°. Among cases in which force was applied at 120°, the load tended to be lower when rat-tooth forceps were applied horizontally across the stent. Conclusions Stent removal was possible in a majority of cases. Deployment of additional stents inside DMS may be preferable to forceful removal in the presence of factors associated with difficult stent removals, such as tumor ingrowth, naïve cases, longer stents, long indwelling time, and stent tearing during removal.
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Affiliation(s)
- Yuto Yamada
- Department of Hepato‐Biliary‐Pancreatic Medicine, Cancer Institute HospitalJapanese Foundation for Cancer ResearchTokyoJapan,Department of Internal MedicineDivision of Gastroenterology and HepatologyToho University, Omori Medical CenterTokyoJapan
| | - Takashi Sasaki
- Department of Hepato‐Biliary‐Pancreatic Medicine, Cancer Institute HospitalJapanese Foundation for Cancer ResearchTokyoJapan
| | - Tsuyoshi Takeda
- Department of Hepato‐Biliary‐Pancreatic Medicine, Cancer Institute HospitalJapanese Foundation for Cancer ResearchTokyoJapan
| | - Takeshi Okamoto
- Department of Hepato‐Biliary‐Pancreatic Medicine, Cancer Institute HospitalJapanese Foundation for Cancer ResearchTokyoJapan
| | - Takafumi Mie
- Department of Hepato‐Biliary‐Pancreatic Medicine, Cancer Institute HospitalJapanese Foundation for Cancer ResearchTokyoJapan
| | - Chinatsu Yonekura
- Department of Hepato‐Biliary‐Pancreatic Medicine, Cancer Institute HospitalJapanese Foundation for Cancer ResearchTokyoJapan
| | - Takaaki Furukawa
- Department of Hepato‐Biliary‐Pancreatic Medicine, Cancer Institute HospitalJapanese Foundation for Cancer ResearchTokyoJapan
| | - Akiyoshi Kasuga
- Department of Hepato‐Biliary‐Pancreatic Medicine, Cancer Institute HospitalJapanese Foundation for Cancer ResearchTokyoJapan
| | - Masato Matsuyama
- Department of Hepato‐Biliary‐Pancreatic Medicine, Cancer Institute HospitalJapanese Foundation for Cancer ResearchTokyoJapan
| | - Masato Ozaka
- Department of Hepato‐Biliary‐Pancreatic Medicine, Cancer Institute HospitalJapanese Foundation for Cancer ResearchTokyoJapan
| | - Takahisa Matsuda
- Department of Internal MedicineDivision of Gastroenterology and HepatologyToho University, Omori Medical CenterTokyoJapan
| | - Yoshinori Igarashi
- Department of Internal MedicineDivision of Gastroenterology and HepatologyToho University, Omori Medical CenterTokyoJapan
| | - Naoki Sasahira
- Department of Hepato‐Biliary‐Pancreatic Medicine, Cancer Institute HospitalJapanese Foundation for Cancer ResearchTokyoJapan
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Chun JW, Woo SM, Han M, Lee MW, Choi JH, Cho IR, Paik WH, Lee WJ, Ryu JK, Kim YT, Lee SH. Prolonged patency of fully covered self-expandable metal stents with an externally anchored plastic stent in distal malignant biliary obstruction. Endoscopy 2023; 55:563-568. [PMID: 36736351 DOI: 10.1055/a-2013-2034] [Citation(s) in RCA: 7] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/05/2023]
Abstract
BACKGROUND : Fully covered self-expandable metal stents (FCSEMSs) are widely used for endoscopic treatment of distal malignant biliary obstruction (dMBO). We aimed to assess the efficacy of anchoring an external plastic stent to an FCSEMS in dMBO. METHODS : A multicenter retrospective cohort study was performed in patients with dMBO to compare stent patency between FCSEMSs and FCSEMSs with an externally anchored plastic stent (EPS). For external anchoring, a 7-Fr double-pigtail plastic stent (DPPS) was placed first in the bile duct, then an FCSEMS was deployed side-by-side. RESULTS : Among a total of 185 patients, 65 had an FCSEMS alone and 120 had an FCSEMS with an EPS. The median stent patency was significantly longer in the FCSEMS with an EPS group than in the FCSEMS only group (342 vs. 240 days; P = 0.04). The rate of stent migration was significantly lower in the FCSEMS with an EPS group than in the FCSEMS only group (10.8 % vs. 27.7 %; P = 0.01). There were no significant differences in the rates of stent occlusion and adverse events between the two groups. CONCLUSIONS : A novel and simple technique of anchoring an external plastic stent may decrease the risk of FCSEMS migration and prolong stent patency, without significantly increasing the adverse events rate in dMBO.
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Affiliation(s)
- Jung Won Chun
- Center for Liver and Pancreatobiliary Cancer, National Cancer Center, Goyang, South Korea
| | - Sang Myung Woo
- Center for Liver and Pancreatobiliary Cancer, National Cancer Center, Goyang, South Korea
| | - Mira Han
- Biostatistics Collaboration Team, National Cancer Center, Goyang, South Korea
| | - Min Woo Lee
- Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea
| | - Jin Ho Choi
- Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea
| | - In Rae Cho
- Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea
| | - Woo Hyun Paik
- Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea
| | - Woo Jin Lee
- Center for Liver and Pancreatobiliary Cancer, National Cancer Center, Goyang, South Korea
| | - Ji Kon Ryu
- Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea
| | - Yong-Tae Kim
- Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea
| | - Sang Hyub Lee
- Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea
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10
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Takeda T, Sasaki T, Yamada Y, Okamoto T, Mie T, Furukawa T, Kasuga A, Matsuyama M, Ozaka M, Sasahira N. The efficacy and safety of a duckbill-type anti-reflux metal stent as the initial metal stent for distal malignant biliary obstruction in unresectable pancreatic cancer. DEN OPEN 2023; 3:e205. [PMID: 36636718 PMCID: PMC9829095 DOI: 10.1002/deo2.205] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 11/18/2022] [Revised: 12/03/2022] [Accepted: 12/17/2022] [Indexed: 01/11/2023]
Abstract
Background The usefulness of duckbill-type anti-reflux metal stent (DMS) in self-expandable metal stent-naïve pancreatic cancer (PC) patients has not been well-studied. This study aimed to evaluate the efficacy and safety of DMS in such patients. Methods We analyzed consecutive patients with unresectable PC who received a covered metal stent (CMS) as the initial self-expandable metal stent at our institution. Technical success, functional success, causes of recurrent biliary obstruction (RBO), time to RBO (TRBO), adverse events (AEs), and reintervention rates were compared between DMS and conventional CMS (c-CMS). Results A total of 69 patients were included (DMS: 28, c-CMS: 41). Technical success, functional success, and AEs were similar between groups. Tumor ingrowth was more common in the DMS group (18% vs. 0%, p = 0.009), while non-occlusion cholangitis tended to be more common in the c-CMS group (0% vs. 15%, p = 0.074). Median time to RBO was similar between groups (276 vs. 273 days, p = 0.915). The anti-reflux valve of DMS was found torn in 56% of patients. Endoscopic reintervention was successful in all cases, despite failed stent removal in 88% of patients in the DMS group. Conclusions DMS was not associated with longer time to RBO compared to c-CMS in self-expandable metal stent-naïve patients.
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Affiliation(s)
- Tsuyoshi Takeda
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Takashi Sasaki
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Yuto Yamada
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan,Department of Internal medicineDivision of Gastroenterology and HepatologyToho UniversityTokyoJapan
| | - Takeshi Okamoto
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Takafumi Mie
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Takaaki Furukawa
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Akiyoshi Kasuga
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Masato Matsuyama
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Masato Ozaka
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Naoki Sasahira
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
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11
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Miyazawa M, Takatori H, Okafuji H, Hayashi T, Toyama T, Yamada S, Kitamura K, Arai K, Sakai Y, Yamashita T, Yamashita T, Mizukoshi E, Honda M, Kaneko S. Efficacy of a novel self-expandable metal stent with dumbbell-shaped flare ends for distal biliary obstruction due to unresectable pancreatic cancer. Sci Rep 2022; 12:21100. [PMID: 36473910 PMCID: PMC9727129 DOI: 10.1038/s41598-022-25186-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/15/2022] [Accepted: 11/25/2022] [Indexed: 12/12/2022] Open
Abstract
This study aimed to evaluate the efficacy of a novel fully covered self-expandable metal stent (SEMS) with dumbbell-shaped flare ends for the palliation of distal biliary obstruction (DBO) due to unresectable pancreatic cancer (UPC). Patients with DBO due to UPC who received the novel HILZO fully covered stent (HFS), the WALLFLEX partially covered stent (WPS) or fully covered stent (WFS) were analyzed. The incidence of recurrent biliary obstruction (RBO), time to RBO (TRBO), and the incidence of complications were compared among the three SEMS groups. Eighty-four patients (HFS, n = 36; WPS, n = 20; WFS, n = 28) were included. The incidence of RBO was low in the HFS group (versus the WPS and WFS group, p = 0.033 and 0.023, respectively). TRBO in the HFS group was longer than that in the WFS group (p = 0.049). Placement of the HFS was an independent factor for long TRBO in multivariable analysis (p = 0.040). The incidence of pancreatitis and cholecystitis in the HFS group was low (one for each). It is recommended to use the HFS for the palliation of DBO due to UPC from the viewpoint of the low incidence of RBO and complications.
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Affiliation(s)
- Masaki Miyazawa
- grid.412002.50000 0004 0615 9100Department of Gastroenterology, Kanazawa University Hospital, 13-1, Takara-Machi, Kanazawa City, Ishikawa Prefecture 920-8641 Japan
| | - Hajime Takatori
- grid.412002.50000 0004 0615 9100Department of Gastroenterology, Kanazawa University Hospital, 13-1, Takara-Machi, Kanazawa City, Ishikawa Prefecture 920-8641 Japan
| | - Hirofumi Okafuji
- grid.412002.50000 0004 0615 9100Department of Gastroenterology, Kanazawa University Hospital, 13-1, Takara-Machi, Kanazawa City, Ishikawa Prefecture 920-8641 Japan
| | - Tomoyuki Hayashi
- grid.412002.50000 0004 0615 9100Department of Gastroenterology, Kanazawa University Hospital, 13-1, Takara-Machi, Kanazawa City, Ishikawa Prefecture 920-8641 Japan
| | - Tadashi Toyama
- grid.9707.90000 0001 2308 3329Innovative Clinical Research Center, Kanazawa University, 13-1, Takara-Machi, Kanazawa City, Ishikawa Prefecture 920-8641 Japan
| | - Shinya Yamada
- grid.412002.50000 0004 0615 9100Department of Gastroenterology, Kanazawa University Hospital, 13-1, Takara-Machi, Kanazawa City, Ishikawa Prefecture 920-8641 Japan
| | - Kazuya Kitamura
- grid.412002.50000 0004 0615 9100Department of Gastroenterology, Kanazawa University Hospital, 13-1, Takara-Machi, Kanazawa City, Ishikawa Prefecture 920-8641 Japan
| | - Kuniaki Arai
- grid.412002.50000 0004 0615 9100Department of Gastroenterology, Kanazawa University Hospital, 13-1, Takara-Machi, Kanazawa City, Ishikawa Prefecture 920-8641 Japan
| | - Yoshio Sakai
- grid.412002.50000 0004 0615 9100Department of Gastroenterology, Kanazawa University Hospital, 13-1, Takara-Machi, Kanazawa City, Ishikawa Prefecture 920-8641 Japan
| | - Taro Yamashita
- grid.412002.50000 0004 0615 9100Department of Gastroenterology, Kanazawa University Hospital, 13-1, Takara-Machi, Kanazawa City, Ishikawa Prefecture 920-8641 Japan
| | - Tatsuya Yamashita
- grid.412002.50000 0004 0615 9100Department of Gastroenterology, Kanazawa University Hospital, 13-1, Takara-Machi, Kanazawa City, Ishikawa Prefecture 920-8641 Japan
| | - Eishiro Mizukoshi
- grid.412002.50000 0004 0615 9100Department of Gastroenterology, Kanazawa University Hospital, 13-1, Takara-Machi, Kanazawa City, Ishikawa Prefecture 920-8641 Japan
| | - Masao Honda
- grid.412002.50000 0004 0615 9100Department of Gastroenterology, Kanazawa University Hospital, 13-1, Takara-Machi, Kanazawa City, Ishikawa Prefecture 920-8641 Japan
| | - Shuichi Kaneko
- grid.412002.50000 0004 0615 9100Department of Gastroenterology, Kanazawa University Hospital, 13-1, Takara-Machi, Kanazawa City, Ishikawa Prefecture 920-8641 Japan
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12
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Angle of covered self-expandable metallic stents after placement is a risk factor for recurrent biliary obstruction. World J Hepatol 2022. [DOI: 10.4254/wjh.v14.i5.993] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
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13
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Tanoue K, Maruyama H, Ishikawa-Kakiya Y, Kinoshita Y, Hayashi K, Yamamura M, Ominami M, Nadatani Y, Fukunaga S, Otani K, Hosomi S, Tanaka F, Kamata N, Nagami Y, Taira K, Watanabe T, Fujiwara Y. Angle of covered self-expandable metallic stents after placement is a risk factor for recurrent biliary obstruction. World J Hepatol 2022; 14:992-1005. [PMID: 35721297 PMCID: PMC9157710 DOI: 10.4254/wjh.v14.i5.992] [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: 06/08/2021] [Revised: 09/01/2021] [Accepted: 04/24/2022] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Studies have shown that covered self-expandable metallic stents (CSEMS) with a low axial forces after placement can cause early recurrent biliary obstruction (RBO) due to precipitating sludge formation. AIM To ascertain whether the angle of CSEMS after placement is a risk factor for RBO in unresectable distal malignant biliary obstruction (MBO). METHODS Between January 2010 and March 2019, 261 consecutive patients underwent self-expandable metallic stent insertion by endoscopic retrograde cholangiopancreatography at our facility, and 87 patients were included in this study. We evaluated the risk factors for RBO, including the angle of CSEMS after placement as the primary outcome. We measured the obtuse angle of CSEMS after placement on an abdominal radiograph using the SYNAPSE PACS system. We also evaluated technical and functional success, adverse events, time to RBO (TRBO), non-RBO rate, survival time, cause of RBO, and reintervention procedure as secondary outcomes. RESULTS We divided the patients into two cohorts based on the presence or absence of RBO. The angle of CSEMS after placement (per 1° and per 10°) was evaluated using the multivariate Cox proportional hazard analysis, which was an independent risk factor for RBO in unresectable distal MBO [hazard ratio, 0.97 and 0.71; 95% confidence interval (CI): 0.94-0.99 and 0.54-0.92; P = 0.01 and 0.01, respectively]. For early diagnosis of RBO, the cut-off value of the angle of CSEMS after placement using the receiver operating characteristic curve was 130° [sensitivity, 50.0%; specificity 85.5%; area under the curve 0.70 (95%CI: 0.57-0.84)]. TRBO in the < 130° angle group was significantly shorter than that in the ≥ 130° angle group (P < 0.01). CONCLUSION This study suggests that the angle of the CSEMS after placement for unresectable distal MBO is a risk factor for RBO. These novel results provide pertinent information for future stent management.
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Affiliation(s)
- Kojiro Tanoue
- Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka 545-8585, Japan
| | - Hirotsugu Maruyama
- Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka 545-8585, Japan.
| | - Yuki Ishikawa-Kakiya
- Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka 545-8585, Japan
| | - Yosuke Kinoshita
- Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka 545-8585, Japan
| | - Kappei Hayashi
- Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka 545-8585, Japan
| | - Masafumi Yamamura
- Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka 545-8585, Japan
| | - Masaki Ominami
- Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka 545-8585, Japan
| | - Yuji Nadatani
- Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka 545-8585, Japan
| | - Shusei Fukunaga
- Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka 545-8585, Japan
| | - Koji Otani
- Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka 545-8585, Japan
| | - Shuhei Hosomi
- Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka 545-8585, Japan
| | - Fumio Tanaka
- Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka 545-8585, Japan
| | - Noriko Kamata
- Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka 545-8585, Japan
| | - Yasuaki Nagami
- Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka 545-8585, Japan
| | - Koichi Taira
- Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka 545-8585, Japan
| | - Toshio Watanabe
- Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka 545-8585, Japan
| | - Yasuhiro Fujiwara
- Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka 545-8585, Japan
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14
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Shiomi H, Nakano R, Ota S. Covered self-expandable metal stents for distal biliary obstruction from pancreatic carcinoma: what type of stent is preferred? Clin Endosc 2022; 55:369-371. [PMID: 35656628 PMCID: PMC9178144 DOI: 10.5946/ce.2022.122] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/06/2022] [Accepted: 04/13/2022] [Indexed: 11/16/2022] Open
Affiliation(s)
- Hideyuki Shiomi
- Division of Gastroenterology and Hepatobiliary and Pancreatic Diseases, Department of Internal Medicine, Hyogo Medical University, Hyogo, Japan
- Correspondence: Hideyuki Shiomi Division of Gastroenterology and Hepatobiliary and Pancreatic Diseases, Department of Internal Medicine, Hyogo Medical University, 1-1, Mukogawa-Cho, Nishinomiya, Hyogo 663-8501, Japan E-mail:
| | - Ryota Nakano
- Division of Gastroenterology and Hepatobiliary and Pancreatic Diseases, Department of Internal Medicine, Hyogo Medical University, Hyogo, Japan
| | - Shogo Ota
- Division of Gastroenterology and Hepatobiliary and Pancreatic Diseases, Department of Internal Medicine, Hyogo Medical University, Hyogo, Japan
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15
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Kitagawa K, Mitoro A, Ozutsumi T, Furukawa M, Fujinaga Y, Seki K, Nishimura N, Sawada Y, Kaji K, Kawaratani H, Takaya H, Moriya K, Namisaki T, Akahane T, Yoshiji H. Laser-cut-type versus braided-type covered self-expandable metallic stents for distal biliary obstruction caused by pancreatic carcinoma: a retrospective comparative cohort study. Clin Endosc 2022; 55:434-442. [PMID: 34706489 PMCID: PMC9178141 DOI: 10.5946/ce.2021.161] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/17/2021] [Revised: 07/10/2021] [Accepted: 07/11/2021] [Indexed: 12/07/2022] Open
Abstract
BACKGROUND/AIMS Covered self-expandable metallic stents (CMSs) are widely used for malignant distal biliary obstructions (MDBOs) caused by pancreatic carcinoma. This study compared the efficacy and safety of the laser-cut-type and braided-type CMSs. METHODS To palliate MDBOs caused by pancreatic carcinoma, the laser-cut-type CMSs was used from April 2014 to March 2017, and the braided-type CMSs was used from April 2017 to March 2019. The tested self-expandable metallic stents were equipped with different anti-migration systems. RESULTS In total, 47 patients received CMSs for MDBOs (24 laser-cut type, 23 braided-type). The time to recurrent biliary obstruction (TRBO) was significantly longer in the braided-type CMSs (p=0.0008), and the median time to stent dysfunction or patient death was 141 and 265 days in the laser-cut-type CMSs and braided-type CMSs, respectively (p=0.0023). Stent migration was the major cause of stent dysfunction in both groups, which occurred in 37.5% of the laser-cut-type CMSs and 13.0% of the braidedtype CMSs. There were no differences in the survival duration between the groups. CONCLUSION The TRBO was significantly longer for the braided-type CMSs with an anti-migration system than for the laser-cuttype. Stent migration tended to be less frequent with the braided-type CMSs than with the laser-cut-type CMSs.
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Affiliation(s)
- Koh Kitagawa
- Department of Gastroenterology, Nara Medical University, Nara, Japan
| | - Akira Mitoro
- Department of Gastroenterology, Nara Medical University, Nara, Japan
| | - Takahiro Ozutsumi
- Department of Gastroenterology, Nara Medical University, Nara, Japan
| | - Masanori Furukawa
- Department of Gastroenterology, Nara Medical University, Nara, Japan
| | - Yukihisa Fujinaga
- Department of Gastroenterology, Nara Medical University, Nara, Japan
| | - Kenichiro Seki
- Department of Gastroenterology, Nara Medical University, Nara, Japan
| | | | - Yasuhiko Sawada
- Department of Gastroenterology, Nara Medical University, Nara, Japan
| | - Kosuke Kaji
- Department of Gastroenterology, Nara Medical University, Nara, Japan
| | - Hideto Kawaratani
- Department of Gastroenterology, Nara Medical University, Nara, Japan
| | - Hiroaki Takaya
- Department of Gastroenterology, Nara Medical University, Nara, Japan
| | - Kei Moriya
- Department of Gastroenterology, Nara Medical University, Nara, Japan
| | - Tadashi Namisaki
- Department of Gastroenterology, Nara Medical University, Nara, Japan
| | - Takemi Akahane
- Department of Gastroenterology, Nara Medical University, Nara, Japan
| | - Hitoshi Yoshiji
- Department of Gastroenterology, Nara Medical University, Nara, Japan
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16
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Liu M, Tian Y, Cheng J, Zhang Y, Zhao G, Ni Z. Mixed-braided stent: An effective way to improve comprehensive mechanical properties of poly (L-lactic acid) self-expandable braided stent. J Mech Behav Biomed Mater 2022; 128:105123. [DOI: 10.1016/j.jmbbm.2022.105123] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/13/2021] [Revised: 01/31/2022] [Accepted: 02/06/2022] [Indexed: 10/19/2022]
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17
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Okamoto T. Malignant biliary obstruction due to metastatic non-hepato-pancreato-biliary cancer. World J Gastroenterol 2022; 28:985-1008. [PMID: 35431494 PMCID: PMC8968522 DOI: 10.3748/wjg.v28.i10.985] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/20/2021] [Revised: 07/03/2021] [Accepted: 02/16/2022] [Indexed: 02/06/2023] Open
Abstract
Malignant biliary obstruction generally results from primary malignancies of the pancreatic head, bile duct, gallbladder, liver, and ampulla of Vater. Metastatic lesions from other primaries to these organs or nearby lymph nodes are rarer causes of biliary obstruction. The most common primaries include renal cancer, lung cancer, gastric cancer, colorectal cancer, breast cancer, lymphoma, and melanoma. They may be difficult to differentiate from primary hepato-pancreato-biliary cancer based on imaging studies, or even on biopsy. There is also no consensus on the optimal method of treatment, including the feasibility and effectiveness of endoscopic intervention or surgery. A thorough review of the literature on pancreato-biliary metastases and malignant biliary obstruction due to metastatic non-hepato-pancreato-biliary cancer is presented. The diagnostic modality and clinical characteristics may differ significantly depending on the type of primary cancer. Different primaries also cause malignant biliary obstruction in different ways, including direct invasion, pancreatic or biliary metastasis, hilar lymph node metastasis, liver metastasis, and peritoneal carcinomatosis. Metastasectomy may hold promise for some types of pancreato-biliary metastases. This review aims to elucidate the current knowledge in this area, which has received sparse attention in the past. The aging population, advances in diagnostic imaging, and improved treatment options may lead to an increase in these rare occurrences going forward.
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Affiliation(s)
- Takeshi Okamoto
- Department of Gastroenterology, St. Luke’s International Hospital, Chuo-ku 104-8560, Tokyo, Japan
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18
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Isayama H, Fujisawa T, Ishii S, Tomishima K, Ikemura M, Ota H, Kabemura D, Ushio M, Takahashi S, Takasaki Y, Suzuki A, Ito K, Ochiai K, Saito H. Endoscopic Biliary Drainage and Associated Procedures Required for Patients with Malignant Biliary Strictures. THE IASGO TEXTBOOK OF MULTI-DISCIPLINARY MANAGEMENT OF HEPATO-PANCREATO-BILIARY DISEASES 2022:201-208. [DOI: 10.1007/978-981-19-0063-1_24] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/02/2025]
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19
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Zhao G, Wang B, Liu M, Tian Y, Wu G, Zhang Y, Cheng J, Ni Z. A study of the radial and bending performance for poly (L‐lactic acid) braided stents with innovative runners. POLYM ADVAN TECHNOL 2021. [DOI: 10.1002/pat.5461] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
Affiliation(s)
- Gutian Zhao
- School of Mechanical Engineering, Jiangsu Key Laboratory for Design and Manufacture of Micro‐Nano Biomedical Instruments Southeast University Nanjing China
| | - Bin Wang
- School of Mechanical Engineering, Jiangsu Key Laboratory for Design and Manufacture of Micro‐Nano Biomedical Instruments Southeast University Nanjing China
| | - Muqing Liu
- School of Mechanical Engineering, Jiangsu Key Laboratory for Design and Manufacture of Micro‐Nano Biomedical Instruments Southeast University Nanjing China
| | - Yuan Tian
- School of Mechanical Engineering, Jiangsu Key Laboratory for Design and Manufacture of Micro‐Nano Biomedical Instruments Southeast University Nanjing China
| | - Gensheng Wu
- School of Mechanical and Electronic Engineering Nanjing Forestry University Nanjing China
| | - Yi Zhang
- Center of Interventional Radiology & Vascular Surgery, Department of Radiology, Zhongda Hospital, Medical School Southeast University Nanjing China
| | - Jie Cheng
- School of Mechanical Engineering, Jiangsu Key Laboratory for Design and Manufacture of Micro‐Nano Biomedical Instruments Southeast University Nanjing China
| | - Zhonghua Ni
- School of Mechanical Engineering, Jiangsu Key Laboratory for Design and Manufacture of Micro‐Nano Biomedical Instruments Southeast University Nanjing China
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Shah J, Rana SS. Newer Stents for Unresectable Malignant Distal Biliary Obstruction: Striving for Perfection! JOURNAL OF DIGESTIVE ENDOSCOPY 2021. [DOI: 10.1055/s-0041-1728841] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/21/2022] Open
Abstract
AbstractEndoscopic biliary stenting is one of the most commonly used palliative procedure in patients with unresectable malignant distal biliary obstruction. Biliary stenting can be performed with either plastic or metallic stents. Stent occlusion and migration are important limitations of currently available stents. Variety of newer stents with varying designs and stent materials like stents with antimigratory properties, antireflux stents, drug-eluting stents, radioactive stents, and bioabsorbable stents are being developed to overcome the limitations of currently available stents. In this article, we are discussing two articles on the newer stent designs (plastic and metal stents) for biliary drainage in patients with unresectable malignant distal biliary obstruction.
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Affiliation(s)
- Jimil Shah
- Department of Gastroenterology, Post Graduate Institute of Medical Education and Research, Chandigarh, India
| | - Surinder Singh Rana
- Department of Gastroenterology, Post Graduate Institute of Medical Education and Research, Chandigarh, India
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Comparing the 14-mm uncovered and 10-mm covered metal stents in patients with distal biliary obstruction caused by unresectable pancreatic cancer: a multicenter retrospective study. Surg Endosc 2021; 36:736-744. [PMID: 33591450 DOI: 10.1007/s00464-021-08342-z] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/29/2020] [Accepted: 01/27/2021] [Indexed: 02/07/2023]
Abstract
BACKGROUND Endoscopic biliary drainage using metal stent (MSs) is an established palliative treatment for patients with unresectable malignant distal biliary obstruction (MDBO). However, a major drawback of MS is recurrent biliary obstruction (RBO). Uncovered MSs with a diameter of 14 mm (UMS-14) were developed to overcome this. We aimed to compare the clinical outcomes of UMS-14 with those of conventional covered MSs having a diameter of 10 mm (CMS-10). METHODS Consecutive patients with MDBO caused by unresectable pancreatic cancer, who underwent UMS-14 or CMS-10 placement at two tertiary-care centers, were retrospectively examined according to the Tokyo Criteria 2014. RESULTS Two hundred and thirty-eight patients who underwent UMS-14 (the UMS-14 group, n = 80) or CMS-10 (the CMS-10 group, n = 158) over a 62-month period were included. The technical and clinical success rates were similar between the two groups. RBO occurred in 20 (25%) and 59 (37%) patients of the UMS-14 and CMS-10 groups, respectively (p = 0.06). Median time till RBO was significantly longer in the UMS-14 group than in the CMS-10 group (not reached vs. 290 days, p = 0.04). Multivariate analysis revealed that CMS-10 placement was an independent risk factor for RBO (hazard ratio: 1.66, 95% confidence interval: 1.00-2.76). The incidence of early complications, including pancreatitis, and the overall survival (UMS-14 vs. CMS-10: 169 vs. 167 days, p = 0.83) were comparable between the two groups. CONCLUSIONS UMS-14 stents were safe and effective for treating patients with MDBO secondary to unresectable pancreatic cancer. The insertion of UMS-14 is recommended, because it is less likely to get occluded as compared to CMS-10.
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22
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Abstract
Malignant biliary obstruction (MBO), result of pancreatobiliary diseases is a challenging condition. Most patients with MBO are inoperable at the time of diagnosis, and the disease is poorly controlled using external-beam radiotherapy and chemotherapy. Biliary stent therapy emerged as a promising strategy for alleviating MBO and prolonging life. However, physicians find it difficult to determine the optimal type of biliary stent for the palliation of MBO. Here, we review the safety and efficacy of available biliary stents, used alone or in combination with brachytherapy, photodynamic therapy and advanced chemotherapeutics, in patients with pancreatobiliary malignancies and put forward countermeasures involving stent obstruction. Furthermore, 3D-printing stents and nanoparticle-loaded stents have broad application prospects for fabricating tailor-made biliary stents.
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23
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Yamao K, Takenaka M, Ogura T, Hashimoto H, Matsumoto H, Yamamoto M, Ikeura T, Kurita A, Li ZL, Shiomi H, Chiba Y, Kudo M, Sanuki T. Utility and Safety of a Novel Fully Covered Metal Stent in Unresectable Distal Malignant Biliary Obstruction. Dig Dis Sci 2020; 65:3702-3709. [PMID: 32036515 DOI: 10.1007/s10620-020-06114-8] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/18/2019] [Accepted: 01/27/2020] [Indexed: 12/09/2022]
Abstract
BACKGROUND Self-expandable metal stents (SEMSs) are widely used in patients with distal malignant biliary obstruction. A SEMS that can avoid occlusion as much as possible is desirable. AIMS The aim of this multicenter single-arm prospective study was to assess the clinical effectiveness and safety of a novel fully covered braided SEMS. METHODS We enrolled consecutive patients with distal malignant biliary obstruction between February 2016 and November 2017 at ten tertiary-care medical centers. RESULTS We included 79 patients with a median age of 76 years; 47 (59.5%) patients were men. The technical and clinical success rate was 98.7% and 93.6%, respectively. Recurrent biliary obstruction occurred in 14 patients (17.9%); stent ingrowth, overgrowth, migration, and other occurred in five (6.4%), four (5.1%), four (5.1%), and one (1.3%) patients, respectively. All reinterventions in patients with recurrent biliary obstruction were successful via the transpapillary approach. Adverse events occurred in 15 patients (19.2%); cholangitis, pancreatitis, and others occurred in ten (12.8%), three (3.8%), and two (2.6%) patients, respectively. The stent patency probability at 6 months was 48.5%. Median time to stent patency was 171 days, median time to recurrent biliary obstruction was 536 days, and median survival time was 195 days. CONCLUSIONS We confirmed the utility and safety of a novel fully covered braided SEMS with low axial force and high radial force in patients with malignance biliary obstruction. This novel SEMS is recommended in patients with distal malignant biliary obstruction.
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Affiliation(s)
- Kentaro Yamao
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Osaka, 589-8511, Japan.
| | - Mamoru Takenaka
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Osaka, 589-8511, Japan
| | - Takeshi Ogura
- The Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Osaka, 569-8686, Japan
| | - Hiroaki Hashimoto
- Department of Gastroenterology, Bell Land General Hospital, Sakai, Osaka, 599-8247, Japan
| | - Hisakazu Matsumoto
- Department of Gastroenterology, Japanese Red Cross Wakayama Medical Center, Wakayama, 640-8558, Japan
| | - Masashi Yamamoto
- Department of Gastroenterology, Toyonaka Municipal Hospital, Toyonaka, Osaka, 560-8565, Japan
| | - Tsukasa Ikeura
- The Third Department of Internal Medicine, Kansai Medical University, Hirakata, Osaka, 573-1191, Japan
| | - Akira Kurita
- Digestive Disease Center, Kitano Hospital, Osaka, 530-8480, Japan
| | - Zhao Liang Li
- Department of Gastroenterology, Takarazuka City Hospital, Takarazuka, Osaka, 665-0827, Japan
| | - Hideyuki Shiomi
- Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Hyogo, 650-0017, Japan
| | - Yasutaka Chiba
- Clinical Research Center, Kindai University Hospital, Osaka-Sayama, Osaka, 589-8511, Japan
| | - Masatoshi Kudo
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Osaka, 589-8511, Japan
| | - Tsuyoshi Sanuki
- Department of Gastroenterology, Kita-Harima Medical Center, Ono, Hyogo, 675-1392, Japan
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Mukai T. Ways to improve stenting in unresectable malignant distal biliary obstruction: Stent design, intraductal placement, and protective role of an intact papilla? Dig Endosc 2020; 32:891-893. [PMID: 32372424 DOI: 10.1111/den.13714] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Affiliation(s)
- Tsuyoshi Mukai
- Department of Gastroenterology, Gifu Municipal Hospital, Gifu, Japan
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25
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Toyokawa Y, Kobayashi S, Tsuchiya H, Shibuya T, Aoki M, Sumiya J, Ooyama S, Ishizawa T, Makino N, Ueno Y, Tanaka M. A fully covered self-expandable metallic stent coated with poly (2-methoxyethyl acrylate) and its derivative: In vitro evaluation of early-stage biliary sludge formation inhibition. MATERIALS SCIENCE & ENGINEERING. C, MATERIALS FOR BIOLOGICAL APPLICATIONS 2020; 120:111386. [PMID: 33545807 DOI: 10.1016/j.msec.2020.111386] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 02/12/2020] [Revised: 08/07/2020] [Accepted: 08/12/2020] [Indexed: 01/02/2023]
Abstract
The adhesion and deformation behavior of proteins at the inner surface of fully covered, self-expandable metallic stents coated with biocompatible polymers, poly(2-methoxyethyl acrylate) (PMEA) and poly(3-methoxypropyl acrylate) (PMC3A), were analyzed. Model bile solution, proteins, and bacteria were used to unravel the inhibitory ability of the polymer coatings. Adsorbance of proteins and adherence of bacteria were both strongly inhibited by the polymer coatings. Circulation tests were performed under clinical conditions using human bile from patients. Adsorption/deformation of proteins and early-stage sludge formation were inhibited on stent surfaces coated with PMEA derivatives. The present study revealed that early-stage biliary sludge formation on PMEA- and PMC3A-coated stents was suppressed due to the strong resistance of the polymers to protein adsorption/deformation, brought about by intermediate water in hydrated polymer coatings, which is not present in conventional coating materials, such as silicone and polyurethane.
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Affiliation(s)
- Yoshihide Toyokawa
- Former Piolax Medical Devices, Inc., 2265-3 Kamiyabe-Cho, Totsuka-Ku, Yokohama-Shi, Kanagawa 245-0053, Japan
| | - Shingo Kobayashi
- Soft Materials Chemistry, Institute for Materials Chemistry and Engineering, Kyushu University, Build. CE41, 744 Motooka Nishi-ku, Fukuoka 819-0395, Japan
| | - Haruka Tsuchiya
- Former Frontier Center for Organic Materials, Yamagata University, 4-3-16 Jonan, Yonezawa, Yamagata 992-8510, Japan
| | - Tomokazu Shibuya
- Former Frontier Center for Organic Materials, Yamagata University, 4-3-16 Jonan, Yonezawa, Yamagata 992-8510, Japan
| | - Makiko Aoki
- Former Piolax Medical Devices, Inc., 2265-3 Kamiyabe-Cho, Totsuka-Ku, Yokohama-Shi, Kanagawa 245-0053, Japan
| | - Jun Sumiya
- Piolax Medical Devices, Inc., 2265-3 Kamiyabe-Cho, Totsuka-Ku, Yokohama-Shi, Kanagawa 245-0053, Japan
| | - Shun Ooyama
- Piolax Medical Devices, Inc., 2265-3 Kamiyabe-Cho, Totsuka-Ku, Yokohama-Shi, Kanagawa 245-0053, Japan
| | - Tetsuya Ishizawa
- Yamagata University School of Medicine, Course of Internal Medicine and Therapeutics, Department of Gastroenterology and Division of Endoscopy, Yamagata University Hospital, 2-2-2 Iida-nishi, Yamagata 990-9585, Japan
| | - Naohiko Makino
- Yamagata University School of Medicine, Course of Internal Medicine and Therapeutics, Department of Gastroenterology and Division of Endoscopy, Yamagata University Hospital, 2-2-2 Iida-nishi, Yamagata 990-9585, Japan
| | - Yoshiyuki Ueno
- Yamagata University School of Medicine, Course of Internal Medicine and Therapeutics, Department of Gastroenterology and Division of Endoscopy, Yamagata University Hospital, 2-2-2 Iida-nishi, Yamagata 990-9585, Japan
| | - Masaru Tanaka
- Soft Materials Chemistry, Institute for Materials Chemistry and Engineering, Kyushu University, Build. CE41, 744 Motooka Nishi-ku, Fukuoka 819-0395, Japan; Former Frontier Center for Organic Materials, Yamagata University, 4-3-16 Jonan, Yonezawa, Yamagata 992-8510, Japan.
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26
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Emhmed Ali S, Frandah WM, Su L, Fielding C, Mardini H. Should a fully covered self-expandable biliary metal stent be anchored with a double-pigtail plastic stent? A retrospective study. World J Gastrointest Endosc 2019; 11:365-372. [PMID: 31205597 PMCID: PMC6556491 DOI: 10.4253/wjge.v11.i5.365] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/04/2019] [Revised: 04/30/2019] [Accepted: 05/11/2019] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND The migration rate of fully covered self-expandable metal stents (FCSEMSs) has been reported to be between 14% to 37%. Anchoring of FCSEMSs using a double-pigtail plastic stent (DPS) may decrease migration.
AIM To compare stent migration rates between patients who received FCSEMS alone and those who received both an FCSEMS and anchoring DPS.
METHODS We conducted a retrospective analysis of endoscopy reporting system and medical records of 1366 patients who underwent endoscopic retrograde cholangiopancreatography (ERCP) with FCSEMS placement at the University of Kentucky health care. Between July 2015 and April 2017, 203 patients with FCSEMS insertion for the treatment of malignant biliary stricture, benign biliary stricture, post-sphincterotomy bleeding, bile leak, and cholangitis drainage were identified. The review and analysis were conducted through our endoscopy reporting system (ProVation® MD) and medical records. Categorical data were analyzed using Chi-Square and Fischer exact test and continuous data using non-parametric tests. A regression analysis was performed to identify factors independently associated with increased risk of stent migration. We determined an FCSEMS migration endoscopically if the stent was no longer visible in the major papilla.
RESULTS 1366 patients had undergone ERCP by three advanced endoscopists over 21-mo period; among these, 203 patients had FCSEMSs placed. 65 patients had FCSEMSs with DPS, and 138 had FCSEMSs alone. 65 patients had FCSEMSs with DPS, and 138 had FCSEMSs alone. 95 patients had a malignant stricture, 82 patients had a benign stricture, 12 patients had bile leak, 12 patients had cholangitis, and nine patients had post-sphincterotomy bleeding. The migration rate in patients with anchored FCSEMSs with DPS was 6%, and those without anchoring DPS was 10% (P = 0.35). Overall, migration was reported in 18 patients with FCSEMSs placement out of 203 patients with an overall migration rate of 9.7%. There was no significant association between anchoring the FCSEMSs with DPS and the risk of stent migration. Only patients with the previous sphincterotomy and begin biliary stricture were found to have a statistically significant difference in the migration rate between patients who had FCSEMS with DPS and FCSEMS alone (P = 0.01).
CONCLUSION The risk of migration of biliary FCSEMS was 9.7 %. Anchoring an FCSEMS with DPS does not decrease the risk of stent migration.
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Affiliation(s)
- Saad Emhmed Ali
- Department of Internal Medicine, Division of Hospital Medicine, Department of Internal Medicine, University of Kentucky, Lexington, KY 40536, United States
| | - Wesam M Frandah
- Department of Internal Medicine, Division of Gastroenterology, Department of Internal Medicine, University of Kentucky, Lexington, KY 40536, United States
| | - Leon Su
- Department of Statistics, College of Arts and Sciences, College of Public Health, University of Kentucky, Lexington, KY 40536, United States
| | - Cory Fielding
- Department of Internal Medicine, Division of Gastroenterology, Department of Internal Medicine, University of Kentucky, Lexington, KY 40536, United States
| | - Houssam Mardini
- Department of Internal Medicine, Division of Gastroenterology, Department of Internal Medicine, University of Kentucky, Lexington, KY 40536, United States
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A Prospective Multicenter Study of a Fully Covered Metal Stent in Patients with Distal Malignant Biliary Obstruction: WATCH-2 Study. Dig Dis Sci 2018; 63:2466-2473. [PMID: 29218484 DOI: 10.1007/s10620-017-4875-5] [Citation(s) in RCA: 28] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/22/2017] [Accepted: 11/29/2017] [Indexed: 12/12/2022]
Abstract
BACKGROUND Both fully covered (FC) and partially covered (PC) self-expandable metal stents (SEMSs) are now commercially available for distal malignant biliary obstruction (MBO). While FCSEMS can be easily removed at the time of re-interventions, it is theoretically prone to migration. However, few comparative data between FC and PC SEMSs have been reported. AIMS The aim of this study was to compare clinical outcomes of FCSEMS with those of PCSEMS. METHODS This was a multicenter, prospective study of FCSEMS for unresectable distal MBO with a historical control of PCSEMS, which was previously reported as the WATCH study. The primary outcome was recurrent biliary obstruction (RBO), and secondary outcomes were stent migration, stent removal, stent-related adverse events, and survival. RESULTS A total of 151 cases with unresectable distal MBO undergoing FCSEMS placement were enrolled and compared with a historical cohort of 141 cases undergoing PCSEMS placement. No significant differences were found in the rate of RBO (29 vs. 33%; P = 0.451), time to RBO (318 vs. 373 days; P = 0.382), and survival (229 vs. 196 days; P = 0.177) between FCSEMS and PCSEMS. The rate of stent migration also did not differ significantly between the two groups (14 vs. 8%; P = 0.113). The removal of FCSEMSs was successful in all 24 attempted cases (100%). CONCLUSIONS FCSEMSs appeared comparable to PCSEMSs in terms of RBO without a significant increase in stent migration rate in patients with unresectable distal MBO. CLINICAL TRIAL REGISTRATION NUMBER UMIN000007131.
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28
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Minaga K, Kitano M, Itonaga M, Imai H, Miyata T, Yamao K, Tamura T, Nuta J, Warigaya K, Kudo M. Endoscopic ultrasound-guided biliary drainage using a newly designed metal stent with a thin delivery system: a preclinical study in phantom and porcine models. J Med Ultrason (2001) 2017; 45:391-397. [PMID: 29222602 DOI: 10.1007/s10396-017-0850-1] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/03/2017] [Accepted: 11/07/2017] [Indexed: 12/17/2022]
Abstract
PURPOSE This study was designed to evaluate the feasibility and safety of a newly designed self-expandable metal stent for endoscopic ultrasound-guided biliary drainage (EUS-BD) when it was delivered via three different stent delivery systems: a 7.5Fr delivery catheter with a bullet-shaped tip (7.5Fr-bullet), a 7Fr catheter with a bullet-shaped tip (7Fr-bullet), or a 7Fr catheter with a tee-shaped tip (7Fr-tee). METHODS This experimental study utilized a porcine model of biliary dilatation involving ten pigs. In the animal study, technical feasibility and clinical outcomes of the stent when placed with each of the delivery systems were examined. In addition, a phantom model was used to measure the resistance of these delivery systems to advancement. RESULTS Phantom experiments showed that, compared with 7Fr-bullet, 7Fr-tee had less resistance force to the advancement of the stent delivery system. EUS-BD was technically successful in all ten pigs. Fistulous tract dilation was necessary in 100% (2/2), 75% (3/4), and 0% (0/4) of the pigs that underwent EUS-BD using 7.5Fr-bullet, 7Fr-bullet, and 7Fr-tee, respectively. There were no procedure-related complications. CONCLUSION Our newly designed metal stent may be feasible and safe for EUS-BD, particularly when delivered by 7Fr-tee, because it eliminates the need for fistulous tract dilation.
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Affiliation(s)
- Kosuke Minaga
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Masayuki Kitano
- Second Department of Internal Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama, 641-8509, Japan.
| | - Masahiro Itonaga
- Second Department of Internal Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama, 641-8509, Japan
| | - Hajime Imai
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Takeshi Miyata
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Kentaro Yamao
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Takashi Tamura
- Second Department of Internal Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama, 641-8509, Japan
| | - Junya Nuta
- Second Department of Internal Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama, 641-8509, Japan
| | - Kenji Warigaya
- Department of Human Pathology, Wakayama Medical University, Wakayama, Japan
| | - Masatoshi Kudo
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
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29
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Minaga K, Kitano M, Gon C, Yamao K, Imai H, Miyata T, Kamata K, Omoto S, Takenaka M, Kudo M. Endoscopic ultrasonography-guided choledochoduodenostomy using a newly designed laser-cut metal stent: Feasibility study in a porcine model. Dig Endosc 2017; 29:211-217. [PMID: 27681160 DOI: 10.1111/den.12741] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/19/2016] [Accepted: 09/23/2016] [Indexed: 02/08/2023]
Abstract
BACKGROUND AND AIM Endoscopic ultrasonography (EUS)-guided choledochoduodenostomy (EUS-CDS) is increasingly used in the treatment of malignant distal biliary obstruction. Standardized use of this technique requires improvements in instruments, including more convenient and safer devices. The present study was designed to evaluate the resistance force to migration (RFM) of a newly designed laser-cut metal stent and the feasibility of EUS-CDS using this stent. METHODS This experimental study used a porcine model of biliary dilatation involving five male pigs. The new stent is a fully covered laser-cut stent with anti-migration anchoring hooks. The RFM of the new stents was compared with those of three commercially available covered metal stents using a phantom model. In the animal study, after ligation of Vater's ampulla with endoscopic clips, the dilated common bile duct was punctured under EUS guidance, followed by EUS-CDS using the new stent. One week after the procedure, the stents were removed endoscopically and the fistulas were assessed after the pigs were killed. Technical feasibility and clinical outcomes were evaluated. RESULTS Among the four stents, the new stent had the highest RFM. Metal stent placement was successful in all five pigs, with no procedure-related complications occurring during and 1 week after endoscopic intervention. All stents remained in place without migration and were removed easily using a snare. At necropsy, fistulas were created between the bile duct and duodenum in all pigs. CONCLUSION EUS-CDS using a newly designed metal stent was feasible and effective in this porcine model of biliary dilatation.
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Affiliation(s)
- Kosuke Minaga
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Masayuki Kitano
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.,Second Department of Internal Medicine, Wakayama Medical University School of Medicine, Wakayama, Japan
| | - Chimyon Gon
- Research and Development Center, Zeon Corporation, Toyama, Japan
| | - Kentaro Yamao
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Hajime Imai
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Takeshi Miyata
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Ken Kamata
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Shunsuke Omoto
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Mamoru Takenaka
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
| | - Masatoshi Kudo
- Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan
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30
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Isayama H, Nakai Y, Hamada T, Matsubara S, Kogure H, Koike K. Understanding the Mechanical forces of Self-Expandable Metal Stents in the Biliary Ducts. Curr Gastroenterol Rep 2016; 18:64. [PMID: 27778304 DOI: 10.1007/s11894-016-0538-5] [Citation(s) in RCA: 29] [Impact Index Per Article: 3.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/02/2023]
Abstract
Self-expandable metallic stent (SEMS) was an effective biliary endoprosthesis. Mechanical properties of SEMS, radial and axial force (RF, AF), may play important roles in the bile duct after placement. RF was well known dilation force and influenced on the occurrence of migration. AF, newly proposed by this author, was defined as the recovery force when the SEMS vended. AF was related with the cause of bile duct kinking, pancreatitis, and cholecystitis due to the compression of the bile duct, orifice of the cystic duct, and pancreatic orifice. Ideal SEMS may show high RF and low AF.
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Affiliation(s)
- Hiroyuki Isayama
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
| | - Yousuke Nakai
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
| | - Tsuyoshi Hamada
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
| | - Saburo Matsubara
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
| | - Hirofumi Kogure
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
| | - Kazuhiko Koike
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan
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31
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Mukai T, Yasuda I, Isayama H, Iwashita T, Itoi T, Kawakami H, Kogure H, Nakai Y. Pilot study of a novel, large-bore, fully covered self-expandable metallic stent for unresectable distal biliary malignancies. Dig Endosc 2016; 28:671-9. [PMID: 26927207 DOI: 10.1111/den.12643] [Citation(s) in RCA: 24] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/06/2015] [Revised: 02/11/2016] [Accepted: 02/24/2016] [Indexed: 02/06/2023]
Abstract
BACKGROUND AND AIM In patients with unresectable malignant distal biliary obstruction, covered self-expandable metallic stents (CSEMS) may remain patent longer than uncovered self-expandable metallic stents as a result of tumor ingrowth prevention. One main cause of recurrent biliary obstruction (RBO) in CSEMS is sludge formation, which can be prevented using a large-bore stent. Therefore, we developed a novel, 12-mm diameter fully covered SEMS (FCSEMS) and investigated its clinical safety, efficacy, and rate of adverse events. METHODS This prospective, multicenter pilot study, which ran between June 2011 and November 2012, included 38 consecutive patients with unresectable malignant distal biliary obstruction. All patients underwent endoscopic insertion of our novel stent. Primary endpoint was non-RBO rate 6 months after placement. RESULTS Technical and functional success rates of the procedures were 100%. Six-month non-RBO rate was 50%, and median time to RBO was 184 days. Median survival time was 241 days. Twelve patients died within 6 months after stent placement without RBO. RBO was observed in 10 patients (26%), with seven experiencing stent occlusion and three experiencing stent migration. Adverse events other than RBO (at <30 days) developed in six patients (16%; cholecystitis, one; pancreatitis, one; hyperamylasemia, one; pancreatic ductitis, one; abdominal pain, two). Stent removal for reintervention was successfully completed in eight patients. CONCLUSION Our novel FCSEMS may be safe and effective for managing malignant distal obstruction with an acceptable incidence of adverse events.
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Affiliation(s)
- Tsuyoshi Mukai
- Department of Gastroenterology, Gifu Municipal Hospital, Gifu, Japan
| | - Ichiro Yasuda
- Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kawasaki, Japan
| | - Hiroyuki Isayama
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Takuji Iwashita
- Department of Gastroenterology, Graduate School of Medicine, Gifu University, Gifu, Japan
| | - Takao Itoi
- Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan
| | - Hiroshi Kawakami
- Department of Gastroenterology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.,Department of Gastroenterology and Hepatology, Center for Digestive Disease, The University of Miyazaki, Miyazaki, Japan
| | - Hirofumi Kogure
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Yousuke Nakai
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
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Minaga K, Kitano M, Imai H, Harwani Y, Yamao K, Kamata K, Miyata T, Omoto S, Kadosaka K, Sakurai T, Nishida N, Kudo M. Evaluation of anti-migration properties of biliary covered self-expandable metal stents. World J Gastroenterol 2016; 22:6917-6924. [PMID: 27570427 PMCID: PMC4974589 DOI: 10.3748/wjg.v22.i30.6917] [Citation(s) in RCA: 27] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/17/2016] [Revised: 04/04/2016] [Accepted: 04/15/2016] [Indexed: 02/06/2023] Open
Abstract
AIM: To assess anti-migration potential of six biliary covered self-expandable metal stents (C-SEMSs) by using a newly designed phantom model.
METHODS: In the phantom model, the stent was placed in differently sized holes in a silicone wall and retracted with a retraction robot. Resistance force to migration (RFM) was measured by a force gauge on the stent end. Radial force (RF) was measured with a RF measurement machine. Measured flare structure variables were the outer diameter, height, and taper angle of the flare (ODF, HF, and TAF, respectively). Correlations between RFM and RF or flare variables were analyzed using a linear correlated model.
RESULTS: Out of the six stents, five stents were braided, the other was laser-cut. The RF and RFM of each stent were expressed as the average of five replicate measurements. For all six stents, RFM and RF decreased as the hole diameter increased. For all six stents, RFM and RF correlated strongly when the stent had not fully expanded. This correlation was not observed in the five braided stents excluding the laser cut stent. For all six stents, there was a strong correlation between RFM and TAF when the stent fully expanded. For the five braided stents, RFM after full stent expansion correlated strongly with all three stent flare structure variables (ODF, HF, and TAF). The laser-cut C-SEMS had higher RFMs than the braided C-SEMSs regardless of expansion state.
CONCLUSION: RF was an important anti-migration property when the C-SEMS did not fully expand. Once fully expanded, stent flare structure variables plays an important role in anti-migration.
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Isayama H, Nakai Y, Hamada T, Yamamoto N, Koike K. Development of an ideal self-expandable metallic stent design. GASTROINTESTINAL INTERVENTION 2015. [DOI: 10.1016/j.gii.2015.03.002] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/15/2023]
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Nakai Y, Isayama H, Kogure H, Hamada T, Togawa O, Ito Y, Matsubara S, Arizumi T, Yagioka H, Mizuno S, Sasaki T, Yamamoto N, Hirano K, Tada M, Koike K. Risk factors for covered metallic stent migration in patients with distal malignant biliary obstruction due to pancreatic cancer. J Gastroenterol Hepatol 2014; 29:1744-1749. [PMID: 24720610 DOI: 10.1111/jgh.12602] [Citation(s) in RCA: 59] [Impact Index Per Article: 5.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 03/06/2014] [Indexed: 02/06/2023]
Abstract
BACKGROUND AND AIM Covered metallic stents (CMSs) were developed to overcome tumor ingrowth in uncovered metallic stents (UMSs) for malignant biliary obstruction, but superiority of CMSs over UMSs is still controversial due to the high migration rate in CMS. Therefore, we conducted this retrospective analysis to clarify risk factors for stent migration, including mechanical properties of CMSs. METHODS Patients with unresectable pancreatic cancer, receiving CMS for distal malignant biliary obstruction in five tertiary care centers, were retrospectively studied. Univariate and multivariate analyses to identify prognostic factors for early (< 6 months) stent migration were performed using a proportional hazards model with death or stent occlusion without stent migration as a competing risk. Two mechanical properties were included in the analysis: axial force, the recovery force that leads to a CMS straightening, and radial force (RF), the expansion force against the stricture. RESULTS Among 290 patients who received CMS placement for distal malignant biliary obstruction, stent migration rate was 15.2%. CMS migrated early (< 6 months) in 10.0% and distally in 11.7%, respectively. In the multivariate analysis, significant risk factors for early stent migration were chemotherapy (subdistribution hazard ratios [SHR] 4.46, P = 0.01), CMS with low RF (SHR 2.23, P = 0.03), and duodenal invasion (SHR 2.25, P = 0.02). CONCLUSION CMS with low RF, chemotherapy, and duodenal invasion were associated with CMS migration from our study.
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Affiliation(s)
- Yousuke Nakai
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
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Nakai Y, Isayama H, Kawakubo K, Kogure H, Hamada T, Togawa O, Ito Y, Matsubara S, Arizumi T, Yagioka H, Takahara N, Uchino R, Mizuno S, Miyabayashi K, Yamamoto K, Sasaki T, Yamamoto N, Hirano K, Tada M, Koike K. Metallic stent with high axial force as a risk factor for cholecystitis in distal malignant biliary obstruction. J Gastroenterol Hepatol 2014; 29:1557-1562. [PMID: 24628054 DOI: 10.1111/jgh.12582] [Citation(s) in RCA: 58] [Impact Index Per Article: 5.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 02/15/2014] [Indexed: 12/12/2022]
Abstract
BACKGROUND AND AIM Tumor involvement to the orifice of cystic duct (OCD) is a risk factor for cholecystitis after self-expandable metallic stent (SEMS) placement, but its prevention is still difficult. We conducted this multicenter analysis to clarify a type of SEMS or a method to place SEMS which would decrease the incidence of cholecystitis after SEMS placement. METHODS The incidence of cholecystitis was studied in consecutive patients receiving SEMS for distal malignant biliary obstruction in five tertiary care centers. Multiple logistic regression analysis was performed to evaluate risk factors for cholecystitis. RESULTS A total of 376 patients who received SEMS placement for distal malignant biliary obstruction were analyzed. Tumor involvement to OCD was diagnosed in 25.3%. Overall incidence of cholecystitis was 6.9%. Cholecystitis was observed in 8.0% of 300 patients with covered SEMS, 16.8% of 95 patients with tumor involvement to OCD, 10.8% of 234 patients with SEMS of high axial force (AF), and 12.0% of 158 patients with SEMS length ≤ 60 mm. In the multivariate analysis, tumor involvement to OCD (odds ratio [OR] 5.40, P < 0.001), SEMSs with high AF (OR 5.33, P = 0.002), and SEMS length ≤ 60 mm (OR 3.19, P = 0.010) are risk factors. Among patients with tumor involvement to OCD, the incidence of cholecystitis in SEMS with high and low AF was 25.0% and 5.0%, respectively. CONCLUSION This study with an expanded cohort reconfirmed tumor involvement to OCD as a risk factor for cholecystitis after SEMS placement. SEMS with low AF might decrease cholecystitis.
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Affiliation(s)
- Yousuke Nakai
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
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