دورية أكاديمية
أعرض في EDS

Endoscopic powered resection device for residual colonic lesions: the first multicenter, prospective, international clinical study.

التفاصيل البيبلوغرافية
العنوان: Endoscopic powered resection device for residual colonic lesions: the first multicenter, prospective, international clinical study.
المؤلفون: Knabe M; Centrum Gastroenterology Bethanien (CGB), Bethanien Hospital Frankfurt, Germany. Electronic address: Mate.Knabe@kgu.de., Maselli R; Division of Gastroenterology and Digestive Endoscopy, Department of Gastroenterology Humanitas Research Hospital, Milano, Italy., Cesbron-Metivier E; Service d'hépato-gastro-entérologie, CHU Angers, Angers, France., Hollerbach S; Department of Gastroenterology, Allgemeines Krankenhaus Celle, Celle, Germany., Petruzziello L; Digestive Endoscopy Unit, Università Cattolica del Sacro Cuore, Rome, Italy, Digestive Endoscopy Unit, Fondazione Policlinico Universitario A. Gemelli IRCSS, Rome, Italia., Prat F; Endoscopy Unit, Beaujon Hospital, Publique des Hôpitaux de Paris, Clichy, France., Khara HS; Department of Gastroenterology and Hepatology, Geisinger Medical Center, Danville, Pennsylvania, USA., Pioche M; Endoscopy and Gastroenterology Unit, Edouard Herriot Hospital, Hospices Civils de Lyon, Lyon, France., Hartmann D; Department of General Internal Medicine, Diabetology, Gastroenterology and Oncology, Katholisches Klinikum Mainz, Mainz, Germany., Cesaro P; Digestive Endoscopy Unit and Gastroenterology, Fondazione Poliambulanza, Brescia, Italy., Barbaro F; Digestive Endoscopy Unit, Università Cattolica del Sacro Cuore, Rome, Italy, Digestive Endoscopy Unit, Fondazione Policlinico Universitario A. Gemelli IRCSS, Rome, Italia., Berger A; CHU Bordeaux, Department of Gastroenterology and Digestive Endoscopy, Univ. Bordeaux, Bordeaux, France., Spada C; Digestive Endoscopy Unit and Gastroenterology, Fondazione Poliambulanza, Brescia, Italy; Digestive Endoscopy Unit, Università Cattolica del Sacro Cuore, Rome, Italy, Digestive Endoscopy Unit, Fondazione Policlinico Universitario A. Gemelli IRCSS, Rome, Italia., Diehl DL; Department of Gastroenterology and Hepatology, Geisinger Medical Center, Danville, Pennsylvania, USA., May A; Department of Gastroenterology, Oncology and Pneumology, Asklepios Paulinen Klinik, Wiesbaden, Germany., Ponchon T; Endoscopy and Gastroenterology Unit, Edouard Herriot Hospital, Hospices Civils de Lyon, Lyon, France., Repici A; Division of Gastroenterology and Digestive Endoscopy, Department of Gastroenterology Humanitas Research Hospital, Milano, Italy., Costamagna G; Digestive Endoscopy Unit, Università Cattolica del Sacro Cuore, Rome, Italy, Digestive Endoscopy Unit, Fondazione Policlinico Universitario A. Gemelli IRCSS, Rome, Italia.
المصدر: Gastrointestinal endoscopy [Gastrointest Endosc] 2024 May; Vol. 99 (5), pp. 778-786. Date of Electronic Publication: 2023 Dec 01.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Mosby Yearbook Country of Publication: United States NLM ID: 0010505 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1097-6779 (Electronic) Linking ISSN: 00165107 NLM ISO Abbreviation: Gastrointest Endosc Subsets: In Process; MEDLINE
أسماء مطبوعة: Publication: St Louis, Mo : Mosby Yearbook
Original Publication: Denver.
مستخلص: Background and Aims: Endoscopic resection is standard treatment for adenomatous colorectal lesions. Depending on lesion morphology and resection technique, recurrence can occur. Scarred adenomas are challenging to resect and may require surgical management. This study evaluated the safety and effectiveness of an endoscopic powered resection (EPR) system for scarred adenomatous colorectal lesions.
Methods: This single-arm, prospective, multicenter study was conducted from January 2018 to January 2021 at 12 sites. Patients with persistent flat or sessile colorectal lesions were enrolled. Primary end points were technical success (the ability of the device to resect the lesion[s] without use of other resection devices without device-related serious adverse events [AEs]) and safety (the occurrence of AEs through 90 days). Secondary end points included endoscopic confirmation of resection completeness, occurrence of colon stenosis, disease persistence, and diagnostic value of resected specimens.
Results: Sixty-five patients were in the intention-to-treat/safety analysis population. Primary analysis was performed on 45 per-protocol (PP) patients with 48 lesions. All PP patients were solely treated by using the EPR device. Technical success was achieved in 44 (98%) patients. Three (5%) serious AEs occurred: 2 delayed self-limited bleeds and 1 perforation. Nonserious AEs included 4 (6%) cases of mild intraprocedural bleeding. Completeness of resection and histopathologic diagnosis of tissue specimens were achieved in all patients. Twenty-one (46.7%) patients had disease persistence after the first treatment, and there was no colon stenosis.
Conclusions: EPR is safe and effective for benign, persistent, large (>20 mm), scarred colorectal adenomas and should be considered as an alternative treatment in lieu of surgery. A persistence rate of 46.7% indicates that >1 treatment is necessary for effective endoscopic treatment. (Clinical trial registration number: NCT04203667.).
Competing Interests: Disclosure G. Costamagna: Research grants from Cook Medical, Olympus, and Boston Scientific. L. Petruzziello: Research grants from Cook Medical, Olympus, and Boston Scientific. D. L. Diehl: Consultant for Boston Scientific, Olympus, Pentax, Microtech, Steris, Castle Biosciences, Laborie, Actuated Medical, Lumendi, Merit Medical, and One Pass Medical. A. May: Study support from Interscope. A. Repici: Consultant for Boston Scientific, Fujifilm, and ERBE. R. Maselli, Consultant for Boston Scientific, Fujifilm, ERBE, 3D Matrix, and Apollo Endosurgery. All other authors disclosed no financial relationships. The study was sponsored by Interscope, Inc.
(Copyright © 2024. Published by Elsevier Inc.)
سلسلة جزيئية: ClinicalTrials.gov NCT04203667
تواريخ الأحداث: Date Created: 20231202 Latest Revision: 20240422
رمز التحديث: 20240423
DOI: 10.1016/j.gie.2023.11.050
PMID: 38042207
قاعدة البيانات: MEDLINE
الوصف
تدمد:1097-6779
DOI:10.1016/j.gie.2023.11.050