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Zeng Y, Li J, Zheng Y, Zhang D, Zhong N, Zuo X, Li Y, Yu W, Lu J. Development and validation of a predictive model for submucosal fibrosis in patients with early gastric cancer undergoing endoscopic submucosal dissection: experience from a large tertiary center. Ann Med 2024; 56:2391536. [PMID: 39149760 PMCID: PMC11328799 DOI: 10.1080/07853890.2024.2391536] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/30/2024] [Revised: 06/25/2024] [Accepted: 08/02/2024] [Indexed: 08/17/2024] Open
Abstract
BACKGROUND Submucosal fibrosis is associated with adverse events of endoscopic submucosal dissection (ESD). The present study mainly aimed to establish a predictive model for submucosal fibrosis in patients with early gastric cancer (EGC) undergoing ESD. METHODS Eligible patients with EGC, identified at Qilu Hospital of Shandong University from April 2013 to December 2023, were retrospectively included and randomly split into a training set and a validation set in a 7:3 ratio. Logistic regression analyses were used to pinpoint the risk factors for submucosal fibrosis. A nomogram was developed and confirmed using receiver operating characteristic (ROC) curves, calibration plots, Hosmer-Lemeshow (H-L) tests, and decision curve analysis (DCA) curves. Besides, a predictive model for severe submucosal fibrosis was further conducted and tested. RESULTS A total of 516 cases in the training group and 220 cases in the validation group were recruited. The nomogram for submucosal fibrosis contained the following items: tumour location (long axis), tumour location (short axis), ulceration, and biopsy pathology. ROC curves showed high efficiency with an area under the ROC of 0.819 in the training group, and 0.812 in the validation group. Calibration curves and H-L tests indicated good consistency. DCA proved the nomogram to be clinically beneficial. Furthermore, the four items were also applicable for a nomogram predicting severe fibrosis, and the model performed well. CONCLUSION The predictive models, initially constructed in this study, were validated as convenient and feasible for endoscopists to predict submucosal fibrosis and severe fibrosis in patients with EGC undergoing ESD.
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Affiliation(s)
- Yunqing Zeng
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
| | - Jinhou Li
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
- Department of Gastroenterology, Taian City Central Hospital, Taian, Shandong, China
| | - Yuan Zheng
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
| | - Di Zhang
- Department of Medical Oncology, Qilu Hospital of Shandong University, Jinan, Shandong, China
| | - Ning Zhong
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
| | - Xiuli Zuo
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
| | - Yanqing Li
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
| | - Wenbin Yu
- Department of General Surgery, Qilu Hospital of Shandong University, Jinan, Shandong, China
| | - Jiaoyang Lu
- Department of Gastroenterology, Qilu Hospital of Shandong University, Jinan, Shandong, China
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Dave H, Vithalani H, Singh H, Yadav I, Jain A, Kumar S, Bhatia Z, Seshadri S, Hassan S, Dhanka M. Easily injectable gelatin-nonanal hydrogel for endoscopic resectioning of gastrointestinal polyps. Int J Biol Macromol 2024; 279:135405. [PMID: 39245110 DOI: 10.1016/j.ijbiomac.2024.135405] [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: 04/30/2024] [Revised: 08/29/2024] [Accepted: 09/05/2024] [Indexed: 09/10/2024]
Abstract
The use of submucosal injection is crucial for satisfactory submucosal elevation in the early resection of flat polyps originating from the gastrointestinal tract (GIT). Injectable hydrogels derived from natural polypeptides are attractive candidates due to their excellent biocompatibility and easy gelation properties. However, most of the reported hydrogels are not the class of catheter delivery materials due to quick gelation, high inherent viscosity, and injection clogging. This study presents a novel injectable shear-thinning hydrogel platform of small molecules (nonanal) modified gelatin polymer, which offers a promising submucosal injection for effective removal of polyps from GIT. Physicochemical characterizations of hydrogel demonstrate the suitable features as an effective submucosal injection, including shear thinning property, self-assembly, methylene blue dye encapsulation, flow behavior, stability, syringeability (18 G, 21 G, and 24 G needles) and fibrous morphology. Ex vivo investigations of developed submucosal formulation on goat intestines demonstrate the enhanced visibility of cushions and the ability to produce stable, long-lasting cushions of about 8.07 mm up to ∼60 min of submucosal injection. The rapid blood clotting behavior of hydrogel was observed in about 120 s without compromising hemocompatibility with the hemolysis of about 3.77 % only. In vitro biocompatibility of the hydrogel was also verified using the HepG2 and nHDF cells. In vivo study depicts desirable biocompatibility, a non-toxic organ profile, and optimal cushion height in mice models. Studies established the foundation of novel submucosal fluid to improve the therapeutic outcomes of early resection for gastrointestinal polyps.
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Affiliation(s)
- Harshil Dave
- Department of Biological Sciences and Engineering, Indian Institute of Technology Gandhinagar, Gujarat, India
| | - Hitasha Vithalani
- Department of Biological Sciences and Engineering, Indian Institute of Technology Gandhinagar, Gujarat, India
| | - Hemant Singh
- Department of Biological Sciences and Engineering, Indian Institute of Technology Gandhinagar, Gujarat, India; Biological Sciences, Khalifa University of Science and Technology, Abu Dhabi 127788, United Arab Emirates
| | - Indu Yadav
- Department of Biological Sciences and Engineering, Indian Institute of Technology Gandhinagar, Gujarat, India
| | | | - Sunny Kumar
- Institute of Science, Nirma University, Ahmedabad, Gujarat, India
| | - Zeel Bhatia
- Institute of Science, Nirma University, Ahmedabad, Gujarat, India
| | - Sriram Seshadri
- Institute of Science, Nirma University, Ahmedabad, Gujarat, India
| | - Shabir Hassan
- Biological Sciences, Khalifa University of Science and Technology, Abu Dhabi 127788, United Arab Emirates
| | - Mukesh Dhanka
- Department of Biological Sciences and Engineering, Indian Institute of Technology Gandhinagar, Gujarat, India.
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Cocomazzi F, Carparelli S, Labarile N, Capogreco A, Gentile M, Maselli R, Dhar J, Samanta J, Repici A, Hassan C, Perri F, Facciorusso A. Is there a best choice of equipment for colorectal endoscopic submucosal dissection? Expert Rev Med Devices 2024; 21:561-577. [PMID: 38829122 DOI: 10.1080/17434440.2024.2364022] [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: 02/11/2024] [Accepted: 05/31/2024] [Indexed: 06/05/2024]
Abstract
INTRODUCTION Endoscopic submucosal dissection (ESD) is a widely used technique to remove early neoplastic lesions. It was primarily used in the initial days to treat gastric lesions, but recently, the horizon of this endoscopic procedure has expanded, which has allowed us to manage other technically more complex locations, such as the colorectum. AREAS COVERED There has been an exponential growth regarding the wide range of devices available in the market for performing colorectal ESD. As a result, the aim of this review is to highlight the indication of this endoscopic technique, which device is best suited for which indication, as well as future trajectories in this field. EXPERT OPINION Although some devices have proven to be more advantageous than others in this area, very often the choice is still subjective, which is commonly attributed to individual preferences and experience. However, an accurate knowledge of the available tools and their functioning, with their pros and cons, is fundamental for any endoscopist venturing into the field of third space endoscopy. In this way, one can choose which device best suits a particular situation, along with simultaneously having the wealth of knowledge related to therapeutic armamentarium at our disposal in the endoscopy suite.
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Affiliation(s)
- Francesco Cocomazzi
- Gastroenterology and Endoscopy Unit, Fondazione "Casa Sollievo della Sofferenza", IRCCS, San Giovanni Rotondo, Foggia, Italy
| | - Sonia Carparelli
- Gastroenterology and Endoscopy Unit, Fondazione "Casa Sollievo della Sofferenza", IRCCS, San Giovanni Rotondo, Foggia, Italy
| | - Nunzia Labarile
- Department of Gastroenterology, National Institute of Gastroenterology - IRCCS "Saverio de Bellis" - Castellana Grotte, Bari, Italy
| | - Antonio Capogreco
- Endoscopy Unit, Humanitas Clinical and Research Center - IRCCS - Rozzano, Rozzano, Italy
| | - Marco Gentile
- Gastroenterology and Endoscopy Unit, Fondazione "Casa Sollievo della Sofferenza", IRCCS, San Giovanni Rotondo, Foggia, Italy
| | - Roberta Maselli
- Endoscopy Unit, Humanitas Clinical and Research Center - IRCCS - Rozzano, Rozzano, Italy
- Department of Biomedical Sciences, Humanitas University - Rozzano, Foggia, Italy
| | - Jahnvi Dhar
- Department of Gastroenterology, Postgraduate Institute of Medical Education and Research, Chandigarh, India
| | - Jayanta Samanta
- Department of Gastroenterology, Postgraduate Institute of Medical Education and Research, Chandigarh, India
| | - Alessandro Repici
- Endoscopy Unit, Humanitas Clinical and Research Center - IRCCS - Rozzano, Rozzano, Italy
- Department of Biomedical Sciences, Humanitas University - Rozzano, Foggia, Italy
| | - Cesare Hassan
- Endoscopy Unit, Humanitas Clinical and Research Center - IRCCS - Rozzano, Rozzano, Italy
- Department of Biomedical Sciences, Humanitas University - Rozzano, Foggia, Italy
| | - Francesco Perri
- Gastroenterology and Endoscopy Unit, Fondazione "Casa Sollievo della Sofferenza", IRCCS, San Giovanni Rotondo, Foggia, Italy
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Adoor D, Chak A. Submucosal Lifting Agents: An Updated Review. Am J Gastroenterol 2024:00000434-990000000-01212. [PMID: 39092711 DOI: 10.14309/ajg.0000000000002916] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/13/2024] [Accepted: 06/17/2024] [Indexed: 08/04/2024]
Affiliation(s)
- Dayyan Adoor
- Division of Gastroenterology and Liver Disease, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA
| | - Amitabh Chak
- Division of Gastroenterology and Liver Disease, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA
- Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, Ohio, USA
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He XJ, Wang XL, Jiang CS, Hong DG, Lin HL, Zheng YP, Li H, Chen XJ, Huang JX, Dai LS, Liu MY, Luo BX, Li DL, Li DZ, Wang W. Novel beagle model of gastric local fibrotic target lesions for the evaluation and training of endoscopic techniques. BMC Gastroenterol 2023; 23:412. [PMID: 38012582 PMCID: PMC10683295 DOI: 10.1186/s12876-023-03055-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/25/2022] [Accepted: 11/18/2023] [Indexed: 11/29/2023] Open
Abstract
BACKGROUND Novel endoscopic techniques used in the treatment of gastric lesions with local submucosal fibrosis need preclinical evaluation and training due to safety limitations. Therefore, the purpose of our study was to establish an animal model of gastric local fibrotic target lesions and assess its feasibility in the evaluation and training of endoscopic techniques. METHODS In six experimental beagles, a 50% glucose solution was injected into three submucosal areas of the fundus, body, and antrum of the stomach to create gastric local fibrotic target lesions (experimental group). On post-injection day (PID) 7, the injection sites were assessed endoscopically to confirm the presence of submucosal fibrosis formation, and the dental floss clip traction assisted endoscopic submucosal dissection (DFC-ESD) procedure was performed on the gastric local fibrotic target lesions to confirm its feasibility after endoscopic observation. The normal gastric mucosa of six control beagles underwent the same procedure (control group). All the resected specimens were evaluated by histological examination. RESULTS All 12 beagles survived without postoperative adverse events. On PID 7, 16 ulcer changes were observed at the injection sites (16/18) under the endoscope, and endoscopic ultrasonography confirmed the local submucosal fibrosis formation in all ulcer lesions. The subsequent DFC-ESD was successfully performed on the 32 gastric target lesions, and the mean submucosal dissection time in the ulcer lesions was greater than that in the normal gastric mucosa (15.3 ± 5.6 vs. 6.8 ± 0.8 min; P < 0.001). There was no difference in rates of en bloc resection, severe hemorrhage, or perforation between the two groups. Histological analysis of the ulcer lesions showed the absence of epithelial or muscularis mucosae and extensive submucosal fibrous tissue proliferations compared with normal gastric mucosa. Overall, endoscopists had high satisfaction with the realism and feasibility of the animal model. CONCLUSION We developed a novel animal model of gastric local fibrotic target lesions to simulate difficult clinical situations, which strongly appeared to be suitable for the preclinical evaluation and learning of advanced endoscopic techniques.
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Affiliation(s)
- Xiao-Jian He
- Fuzong Clinical Medical College, Fujian Medical University, Fuzhou, China
- Department of Digestive Diseases, 900TH Hospital of Joint Logistics Support Force, 156 North Road of West No.2 Ring, Fuzhou, 350025, China
| | - Xiao-Ling Wang
- Fuzong Clinical Medical College, Fujian Medical University, Fuzhou, China
- Department of Digestive Diseases, 900TH Hospital of Joint Logistics Support Force, 156 North Road of West No.2 Ring, Fuzhou, 350025, China
| | - Chuan-Shen Jiang
- Fuzong Clinical Medical College, Fujian Medical University, Fuzhou, China
- Department of Digestive Diseases, 900TH Hospital of Joint Logistics Support Force, 156 North Road of West No.2 Ring, Fuzhou, 350025, China
| | - Dong-Gui Hong
- Fuzong Clinical Medical College, Fujian Medical University, Fuzhou, China
- Department of Digestive Diseases, 900TH Hospital of Joint Logistics Support Force, 156 North Road of West No.2 Ring, Fuzhou, 350025, China
| | - Hai-Lan Lin
- Fuzong Clinical Medical College, Fujian Medical University, Fuzhou, China
- Department of Digestive Diseases, 900TH Hospital of Joint Logistics Support Force, 156 North Road of West No.2 Ring, Fuzhou, 350025, China
| | - Yun-Ping Zheng
- Fuzong Clinical Medical College, Fujian Medical University, Fuzhou, China
- Department of Digestive Diseases, 900TH Hospital of Joint Logistics Support Force, 156 North Road of West No.2 Ring, Fuzhou, 350025, China
| | - Han Li
- Fuzong Clinical Medical College, Fujian Medical University, Fuzhou, China
- Department of Digestive Diseases, 900TH Hospital of Joint Logistics Support Force, 156 North Road of West No.2 Ring, Fuzhou, 350025, China
| | - Xin-Jiang Chen
- Fuzong Clinical Medical College, Fujian Medical University, Fuzhou, China
- Department of Digestive Diseases, 900TH Hospital of Joint Logistics Support Force, 156 North Road of West No.2 Ring, Fuzhou, 350025, China
| | - Jian-Xiao Huang
- Fuzong Clinical Medical College, Fujian Medical University, Fuzhou, China
- Department of Digestive Diseases, 900TH Hospital of Joint Logistics Support Force, 156 North Road of West No.2 Ring, Fuzhou, 350025, China
| | - Ling-Shuang Dai
- Fuzong Clinical Medical College, Fujian Medical University, Fuzhou, China
- Department of Digestive Diseases, 900TH Hospital of Joint Logistics Support Force, 156 North Road of West No.2 Ring, Fuzhou, 350025, China
| | - Mei-Yan Liu
- Fuzong Clinical Medical College, Fujian Medical University, Fuzhou, China
- Department of Digestive Diseases, 900TH Hospital of Joint Logistics Support Force, 156 North Road of West No.2 Ring, Fuzhou, 350025, China
| | - Bao-Xiang Luo
- Fuzong Clinical Medical College, Fujian Medical University, Fuzhou, China
- Department of Digestive Diseases, 900TH Hospital of Joint Logistics Support Force, 156 North Road of West No.2 Ring, Fuzhou, 350025, China
| | - Dong-Liang Li
- Fuzong Clinical Medical College, Fujian Medical University, Fuzhou, China.
- Department of Hepatobiliary Disease, 900TH Hospital of Joint Logistics Support Force, 156 North Road of West No.2 Ring, Fuzhou, 350025, China.
| | - Da-Zhou Li
- Fuzong Clinical Medical College, Fujian Medical University, Fuzhou, China.
- Department of Digestive Diseases, 900TH Hospital of Joint Logistics Support Force, 156 North Road of West No.2 Ring, Fuzhou, 350025, China.
| | - Wen Wang
- Fuzong Clinical Medical College, Fujian Medical University, Fuzhou, China.
- Department of Digestive Diseases, 900TH Hospital of Joint Logistics Support Force, 156 North Road of West No.2 Ring, Fuzhou, 350025, China.
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Takatori Y, Uraoka T, Sasaki M, Narita T, Yunoki S, Shiraishi J, Yahagi N. Potential of temperature-response collagen-genipin sol as a novel submucosal injection agent for endoscopic resection: Acute and chronic phase study using living animals. Dig Endosc 2022; 35:471-480. [PMID: 36219497 DOI: 10.1111/den.14452] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/13/2022] [Accepted: 10/03/2022] [Indexed: 02/08/2023]
Abstract
OBJECTIVES We proposed a novel temperature-response collagen sol as a submucosal injection agent for endoscopic resection (ER) using pepsin-solubilized collagen (PSC) and genipin (Ge) in a prior study. This study aimed to evaluate the usefulness and safety of the sol (PSC/Ge) in acute and chronic phase experiments using living animals. METHODS In experiment 1, we performed endoscopic submucosal dissection (ESD) for six pigs using normal saline (NS), sodium hyaluronate (SH), and PSC/Ge. We compared the required amount of each agent per unit area and procedure time. In experiment 2, we created artificial ulcers with endoscopic mucosal resection (EMR) for five pigs using NS and PSC sol. We compared the artificial ulcer residual rate at 7 and 14 days after EMR, and the scarring rate at 14 days after EMR. RESULTS The required amount of agents per unit area for PSC/Ge (0.8 ± 0.8 mL/cm2 ) and SH (1.1 ± 0.8 mL/cm2 ) were significantly smaller than that for NS (1.8 ± 0.7 mL/cm2 ). The total procedure time did not have a statistical difference. The artificial ulcer residual rates were 47.3 ± 0.7% for NS and 40.3 ± 0.7% for PSC/Ge on day 7 (P = 0.51), and 15.0 ± 0.1% for NS and 10.2 ± 0.1% for PSC/Ge sol on day 14 (P = 0.35). The scarring rate on day 14 was 10% for NS and 20% for PSC/Ge. CONCLUSION We demonstrated the feasibility of a novel temperature-response collagen gel as a submucosal injection agent for ER in the acute and chronic phase animal experiment.
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Affiliation(s)
- Yusaku Takatori
- Department of Gastroenterology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.,Division of Research and Development for Minimally Invasive Treatment, Cancer Center, Keio University School of Medicine, Tokyo, Japan
| | - Toshio Uraoka
- Department of Gastroenterology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan.,Department of Gastroenterology and Hepatology, Gunma University Graduate School of Medicine, Gunma, Japan
| | - Motoki Sasaki
- Division of Research and Development for Minimally Invasive Treatment, Cancer Center, Keio University School of Medicine, Tokyo, Japan
| | - Takefumi Narita
- Biotechnology Group, Tokyo Metropolitan Industrial Technology Research Institute, Tokyo, Japan
| | - Shunji Yunoki
- Biotechnology Group, Tokyo Metropolitan Industrial Technology Research Institute, Tokyo, Japan.,Institute for the Promotion of Business-Regional Collaboration, Hokkaido University, Hokkaido, Japan
| | - Junichi Shiraishi
- Department of Pathology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan
| | - Naohisa Yahagi
- Division of Research and Development for Minimally Invasive Treatment, Cancer Center, Keio University School of Medicine, Tokyo, Japan
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Brand M, Bachmann J, Schlag C, Huegle U, Rahman I, Wedi E, Walter B, Möschler O, Sturm L, Meining A. Over-the-scope-grasper: A new tool for pancreatic necrosectomy and beyond - first multicenter experience. World J Gastrointest Surg 2022; 14:799-808. [PMID: 36157364 PMCID: PMC9453329 DOI: 10.4240/wjgs.v14.i8.799] [Citation(s) in RCA: 11] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/14/2022] [Revised: 05/08/2022] [Accepted: 08/01/2022] [Indexed: 02/07/2023] Open
Abstract
BACKGROUND Endoscopic treatment of pancreatic necrosis can be challenging and time-consuming because sticky necrotic debris is sometimes difficult to remove. The over-the-scope-grasper, a new tool that has recently become available for this purpose, might also be useful for other indications. However, clinical data on the efficacy and safety of this new device are lacking.
AIM To evaluate the technical success and safety of the device in a multicenter setting.
METHODS The over-the-scope-grasper was used in nine selected endoscopic centers between November 2020 and October 2021 for appropriate indications. Overall, 56 procedures were included in the study. We retrospectively evaluated procedural parameters of all endoscopic interventions using a predefined questionnaire, with special respect to technical success, indications, duration of intervention, type of sedation, and complications. In the case of pancreatic necrosectomy, the access route, stent type, number of necrosis pieces removed, and clinical handling were also recorded.
RESULTS A total of 56 procedures were performed, with an overall technical success rate of 98%. Most of the procedures were endoscopic pancreatic necrosectomies (33 transgastric, 4 transduodenal). In 70% of the procedures, access to the necrotic cavity was established with a lumen apposing metal stent. The technical success of pancreatic necrosectomy was 97%, with a mean of 8 pieces (range, 2-25 pieces) of necrosis removed in a mean procedure time of 59 min (range, 15-120 min). In addition, the device has been used to remove blood clots (n = 6), to clear insufficiency cavities before endoluminal vacuum therapy (n = 5), and to remove foreign bodies from the upper gastrointestinal tract (n = 8). In these cases, the technical success rate was 100%. No moderate or severe/fatal complications were reported in any of the 56 procedures.
CONCLUSION These first multicenter data demonstrate that the over-the-scope-grasper is a promising device for endoscopic pancreatic necrosectomy, which is also appropriate for removing foreign bodies and blood clots, or cleaning insufficiency cavities prior to endoluminal vacuum therapy.
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Affiliation(s)
- Markus Brand
- Department of Internal Medicine II, University of Würzburg, Würzburg 97080, Germany
| | - Jeannine Bachmann
- Department of Surgery, Klinikum rechts der Isar, University of München, München 81675, Germany
| | - Christoph Schlag
- Department of Gastroenterology and Hepatology, University of Zürich, Zürich 8091, Switzerland
| | - Ulrich Huegle
- Department of Gastroenterology and Hepatology, Klinikum Köln-Holweide, Köln 50968, Germany
| | - Imdadur Rahman
- Department of Gastroenterology, University Hospital Southampton, Southampton SO16 6YD, United Kingdom
| | - Edris Wedi
- Department of Gastroenterology, Gastrointestinal Oncology and Interventionell Endoscopy, Sana Klinikum Offenbach, Offenbach 63069, Germany
| | - Benjamin Walter
- Department of Internal Medicine I, University of Ulm, Ulm 89070, Germany
| | - Oliver Möschler
- Department of Gastroenterology, Marienhospital Osnabrück, Osnabrück 49074, Germany
| | - Lukas Sturm
- Department of Internal Medicine II, University of Freiburg, Freiburg 79106, Germany
| | - Alexander Meining
- Department of Internal Medicine II, University of Würzburg, Würzburg 97080, Germany
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Castillo-Regalado E, Uchima H. Endoscopic management of difficult laterally spreading tumors in colorectum. World J Gastrointest Endosc 2022; 14:113-128. [PMID: 35432746 PMCID: PMC8984535 DOI: 10.4253/wjge.v14.i3.113] [Citation(s) in RCA: 6] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/30/2021] [Revised: 11/01/2021] [Accepted: 02/16/2022] [Indexed: 02/06/2023] Open
Abstract
Due to the advent of the screening programs for colorectal cancer and the era of quality assurance colonoscopy the number the polyps that can be considered difficult, including large (> 20 mm) laterally spreading tumors (LSTs), has increased in the last decade. All LSTs should be assessed carefully, looking for suspicious areas of submucosal invasion (SMI), such as nodules or depressed areas, describing the morphology according to the Paris classification, the pit pattern, and vascular pattern. The simplest, most appropriate and safest endoscopic treatment with curative intent should be selected. For LST-granular homogeneous type, piecemeal endoscopic mucosal resection should be the first option due to its biological low risk of SMI. LST-nongranular pseudodepressed type has an increased risk of SMI, and en bloc resection should be mandatory. Underwater endoscopic mucosal resection is useful in situations where submucosal injection alters the operative field, e.g., for the resection of scar lesions, with no lifting, adjacent tattoo, incomplete resection attempts, lesions into a colonic diverticulum, in ileocecal valve and lesions with intra-appendicular involvement. Endoscopic full thickness resection is very useful for the treatment of difficult to resect lesions of less than 20 up to 25 mm. Among the indications, we highlight the treatment of polyps with suspected malignancy because the acquired tissue allows an exact histologic risk stratification to assign patients individually to the best treatment and avoid surgery for low-risk lesions. Endoscopic submucosal dissection is the only endoscopic procedure that allows completes en bloc resection regardless of the size of the lesion. It should therefore be indicated in the treatment of lesions with risk of SMI.
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Affiliation(s)
- Edgar Castillo-Regalado
- Endoscopy Unit, Department of Gastroenterology, Hospital Universitari Germans Trias i Pujol, Barcelona 08916, Spain
- Endoscopic Unit, Creu Groga Medical Center, Calella 08370, Spain
| | - Hugo Uchima
- Endoscopy Unit, Department of Gastroenterology, Hospital Universitari Germans Trias i Pujol, Barcelona 08916, Spain
- Endoscopic Unit, Teknon Medical Center, Barcelona 08022, Spain
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9
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Chen C, Liu XY, Cheng CE, Xiong YJ, Sun YB, Tan CH, Liu YT, Feng J, Ma YF, Shi DT, Li R. Efficacy and safety of a novel submucosal injection solution for endoscopic resection in porcine models. J Dig Dis 2021; 22:49-56. [PMID: 33236832 DOI: 10.1111/1751-2980.12963] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/23/2020] [Revised: 11/17/2020] [Accepted: 11/22/2020] [Indexed: 12/11/2022]
Abstract
OBJECTIVE A submucosal injection is usually required to improve the efficacy and safety of endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR). This study aimed to evaluate the performance of 3.3% sodium carboxymethyl starch (Na-CMS) solution, a novel submucosal injection solution, for ESD and EMR. METHODS Na-CMS, normal saline (NS) and two commercially available agents (sigMAVisc and Eleview) were injected into the esophageal submucosa of randomly grouped pigs. The level of submucosal elevation was examined. Subsequently, ESD or EMR procedures using 3.3% Na-CMS or NS as submucosal injections were performed in the gastrointestinal tract of the pigs. RESULTS Submucosal elevation was significantly higher and more sustained in the 3.3% Na-CMS group than in the controls (P < 0.05). The volume required for ESD or EMR was significantly lower in the 3.3% Na-CMS group than in the NS group (ESD: 12.21 ± 4.09 mL vs 28.25 ± 8.02 mL, P < 0.001; EMR: 3.99 ± 1.98 mL vs 7.15 ± 3.67 mL, P = 0.001). The ESD resection time was significantly shorter in the 3.3% Na-CMS group than in the NS group (16.58 ± 7.30 min vs 25.29 ± 11.89 min, P = 0.004). Hemorrhage after ESD in the 3.3% Na-CMS group was less severe than that in the NS group (P = 0.006). CONCLUSION 3.3% Na-CMS is an effective, safe and low-cost submucosal injection solution and holds promise as preferable agent for submucosal injection in ESD and EMR procedures.
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Affiliation(s)
- Chen Chen
- Department of Gastroenterology, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu Province, China
| | - Xiao Yu Liu
- Department of Gastroenterology, Yulin No. 2 Hospital, Yulin, Shaanxi Province, China
| | - Cui E Cheng
- Department of Gastroenterology, Changshu No. 2 People's Hospital, Changshu, Jiangsu Province, China
| | - Yu Jia Xiong
- Department of Gastroenterology, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu Province, China
| | - Yi Bin Sun
- Department of Gastroenterology, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu Province, China
| | - Chen Huan Tan
- Department of Gastroenterology, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu Province, China
| | - Yi Ting Liu
- Department of Gastroenterology, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu Province, China
| | - Ji Feng
- Department of Gastroenterology, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu Province, China
| | - Yi Fan Ma
- Department of Gastroenterology, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu Province, China
| | - Dong Tao Shi
- Department of Gastroenterology, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu Province, China
| | - Rui Li
- Department of Gastroenterology, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu Province, China
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Arantes V, Aliaga Ramos J, Abdul Rani R, Yoshida N. Off-label use of 0.4 % sodium hyaluronate teardrops: a safe and effective solution for submucosal injection in gastric endoscopic submucosal dissection. Endosc Int Open 2020; 8:E1741-E1747. [PMID: 33269305 PMCID: PMC7671769 DOI: 10.1055/a-1265-6598] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/02/2020] [Accepted: 08/06/2020] [Indexed: 12/02/2022] Open
Abstract
Background and study aims Submucosal (SM) injection is a critical step in endoscopic submucosal dissection (ESD). In Japan, use of viscous solutions such as sodium hyaluronate are recommended; the commercially product available is MucoUp (Seikagaku Co. and Boston Scientific Japan Co., Japan). Nevertheless, MucoUp is expensive and unavailable in many Western countries. For the past 8 years, we have been using low-cost sterile teardrops solution composed of 0.4 % sodium hyaluronate (Adaptis Fresh, Legrand Laboratory, Brazil). This solution is readily available in drugstores with a cost of approximately US$ 10.00 for each 10-cc bottle. The aim of this study was to present the clinical outcome with off-label sodium hyaluronate use for SM injection in gastric ESD. Patients and methods A single-center retrospective study of collected data investigating consecutive patients that underwent gastric ESD between 2012 and 2019. ESD was performed using 0.4 % sodium hyaluronate teardrop for SM injection and Flush Knife BT 2.5 (Fujifilm Co., Japan). The following data were analyzed: clinical-pathological features, en-bloc, R0 and curative resection rate, procedure duration, adverse events, and clinical outcome. Results ESD was performed with sodium hyaluronate for submucosal injection in 78 patients. The en-bloc resection rate and R0 resection rate were 96.1 % and 92.3 %, respectively. The curative resection rate for epithelial lesions was 83.8 %. Adverse events occurred in 5 cases (6.3 %): delayed bleeding (3.8 %, 3 cases) and perforation (2.5 %, 2 cases); all managed successfully by clipping and thermal coagulation. The mean volume of sodium hyaluronate solution used per patient was 10 cc (SD: ± 8 cc). During follow-up (mean: 17 months; SD: ± 14.5 months), two patients developed metachronous lesions (2.5 %). Conclusions Off-label use of teardrops with 0.4 % sodium hyaluronate for submucosal injection was demonstrated to be safe and able to provide an effective submucosal cushion that facilitates SM dissection in gastric ESD procedures.
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Affiliation(s)
- Vitor Arantes
- Faculdade de Medicina da Universidade Federal de Minas Gerais – Alfa Institute of Gastroenterology, Minas Gerais, Brazil
- Hospital Mater Dei Contorno – Endoscopy, Minas Gerais, Brazil
| | | | - Rafiz Abdul Rani
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Universiti Teknologi MARA, Gastroenterology Unit, Faculty of Medicine,
Selangor, Malaysia
| | - Naohisa Yoshida
- Kyoto Prefectural University of Medicine, Molecular Gastroenterology and Hepatology, Kyoto, Japan
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11
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Evaluations on laser ablation of ex vivo porcine stomach tissue for development of Ho:YAG-assisted endoscopic submucosal dissection (ESD). Lasers Med Sci 2020; 36:1437-1444. [PMID: 33156475 DOI: 10.1007/s10103-020-03182-0] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/14/2020] [Accepted: 11/03/2020] [Indexed: 02/07/2023]
Abstract
Endoscopic submucosal dissection (ESD) is clinically used to remove early gastric cancer in stomach. The aim of the current study is to examine a therapeutic capacity of pulsed Ho:YAG laser for the development of laser-assisted ESD under various surgical parameters. Ex vivo porcine stomach tissue was ablated with 1-J Ho:YAG pulses at 10 Hz at different number of treatments (NT = 1, 2, and 3) and treatment speeds (TS = 0.5, 1, and 2 mm/s) without and with saline injection. Regardless of saline injection, straight tissue ablation showed that ablation depth increased with increasing NT and decreasing TS. At NT = 3 and TS = 0.5 mm/s, no saline injection yielded the maximum ablation depth (3.4 ± 0.3 mm), partially removing muscularis propria. However, saline injection confined the tissue ablation within a submucosal layer (2.1 ± 0.3 mm). Thermal injury was found to be 0.7~1.1 mm in the adjacent tissue with superficial carbonization. Circular tissue ablation (2 cm in diameter) at NT = 3 and TS = 0.5 mm/s presented that no saline injection yielded a reduction in the lesion area, whereas saline injection maintained the ablated lesion area. Histological analysis revealed that unlike no saline injection, saline injection ablated the entire mucosal layer without perforation in the muscular propria. The pulsed Ho:YAG laser can be a potential surgical tool for clinical ESD to incise a target lesion without adverse perforation. Further investigations will validate the efficacy and safety of the Ho:YAG laser-assisted ESD in in vivo porcine stomach models for clinical translation.
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Yoshida T, Hirose R, Naito Y, Inoue K, Dohi O, Yoshida N, Kamada K, Uchiyama K, Ishikawa T, Takagi T, Konishi H, Nakaya T, Itoh Y. Viscosity: An important factor in predicting the performance of submucosal injection materials. MATERIALS & DESIGN 2020; 195:109008. [DOI: 10.1016/j.matdes.2020.109008] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 09/11/2023]
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13
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Sportes A, Cfm J, Gromski MA, Koehler P, Seif Amir Hosseini A, Kauffmann P, Ellenrieder V, Wedi E. Novel modified endoscopic mucosal resection of large GI lesions (> 20 mm) using an external additional working channel (AWC) may improve R0 resection rate: initial clinical experience. BMC Gastroenterol 2020; 20:195. [PMID: 32560696 PMCID: PMC7304141 DOI: 10.1186/s12876-020-01344-6] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/22/2019] [Accepted: 06/11/2020] [Indexed: 02/07/2023] Open
Abstract
Background En-bloc resection of large, flat dysplastic mucosal lesions of the luminal GI tract can be challenging. In order to improve the efficacy of resection for lesions ≥2 cm and to optimize R0 resection rates of lesions suspected of harboring high-grade dysplasia or early adenocarcinoma, a novel grasp and snare EMR technique utilizing a novel over the scope additional accessory channel, termed EMR Plus (EMR+), was developed. The aim of this pilot study is to describe the early safety and efficacy data from the first in human clinical cases. Methods A novel external over-the-scope additional working channel (AWC) (Ovesco, Tuebingen, Germany) was utilized for the EMR+ procedure, allowing a second endoscopic device to be used through the AWC while using otherwise standard endoscopic equipment. The EMR+ technique allows tissue retraction and a degree of triangulation during endoscopic resection. We performed EMR+ procedure in 6 patients between 02/2018–12/2018 for lesions in the upper and lower GI tract. Results The EMR+ technique utilizing the AWC was performed successfully in 6 resection procedures of the upper and/or lower GI tract in 6 patients in 2 endoscopy centers. All resections were performed successfully with the EMR+ technique, all achieving an R0 resection. No severe adverse events occurred in any of the procedures. Conclusions The EMR+ technique, utilizing an additional working channel, had an acceptable safety and efficacy profile in this preliminary study demonstrating it’s first use in humans. This technique may allow an additional option to providers to remove complex, large mucosal-based lesions in the GI tract using standard endoscopic equipment and a novel AWC device.
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Affiliation(s)
- A Sportes
- Department of Gastroenterology, Institut Arnault Tzanck, Saint Laurent du Var, France
| | - Jung Cfm
- Department of Gastroenterology and Gastrointestinal Oncology, Interdisciplinary Endoscopy, University Medical Center, Georg-August-University, 37075, Goettingen, Germany
| | - M A Gromski
- Division of Gastroenterology and Hepatology, Indiana University School of Medicine, Indianapolis, IN, USA
| | - P Koehler
- Institute of Farm Animal Genetics, Friedrich-Loeffler-Institut (FLI), Federal Research Institute for Animal Health, Mariensee, Germany
| | - A Seif Amir Hosseini
- Department of Diagnostic and Interventional Radiology, University Medical Center, Göttingen, Germany
| | - P Kauffmann
- Department of Oral and Maxillofacial Surgery, University Medical Center Goettingen, Göttingen, Germany
| | - V Ellenrieder
- Department of Gastroenterology and Gastrointestinal Oncology, Interdisciplinary Endoscopy, University Medical Center, Georg-August-University, 37075, Goettingen, Germany
| | - E Wedi
- Department of Gastroenterology and Gastrointestinal Oncology, Interdisciplinary Endoscopy, University Medical Center, Georg-August-University, 37075, Goettingen, Germany.
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Chen X, Nishiguchi A, Taguchi T. Adhesive Submucosal Injection Material Based on the Nonanal Group-Modified Poly(vinyl alcohol)/α-Cyclodextrin Inclusion Complex for Endoscopic Submucosal Dissection. ACS APPLIED BIO MATERIALS 2020; 3:4370-4379. [DOI: 10.1021/acsabm.0c00384] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Affiliation(s)
- Xi Chen
- Polymer-Bio Field, Research Center for Functional Materials, National Institute for Materials Science, 1-1 Namiki, Tsukuba, Ibaraki 305-0044, Japan
| | - Akihiro Nishiguchi
- Polymer-Bio Field, Research Center for Functional Materials, National Institute for Materials Science, 1-1 Namiki, Tsukuba, Ibaraki 305-0044, Japan
| | - Tetsushi Taguchi
- Polymer-Bio Field, Research Center for Functional Materials, National Institute for Materials Science, 1-1 Namiki, Tsukuba, Ibaraki 305-0044, Japan
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15
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Kuwai T, Tamaru Y, Kusunoki R, Ishaq S. Submucosal Injection Solutions for ESD: Separating the Winners from the Losers. Dig Dis Sci 2019; 64:2699-2700. [PMID: 31363953 DOI: 10.1007/s10620-019-05743-y] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/20/2023]
Affiliation(s)
- Toshio Kuwai
- Department of Gastroenterology, National Hospital Organization, Kure Medical Center and Chugoku Cancer Center, 3-1 Aoyama-cho, Kure, 737-0023, Japan.
| | - Yuzuru Tamaru
- Department of Gastroenterology, National Hospital Organization, Kure Medical Center and Chugoku Cancer Center, 3-1 Aoyama-cho, Kure, 737-0023, Japan
| | - Ryusaku Kusunoki
- Department of Gastroenterology, National Hospital Organization, Kure Medical Center and Chugoku Cancer Center, 3-1 Aoyama-cho, Kure, 737-0023, Japan
| | - Sauid Ishaq
- Gastroenterology Department, Dudley Group Hospitals, Birmingham City University, Birmingham, UK.,St. George's University, St. George's, Grenada
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