Safety and efficacy of a novel resection system for direct endoscopic necrosectomy of walled-off pancreas necrosis: a prospective, international, multicenter trial

Pauline M.C. Stassen, Pieter Jan F. de Jonge, Marco J. Bruno, Arjun D. Koch, Arvind J. Trindade, Petros C. Benias, Divyesh V. Sejpal, Uzma D. Siddiqui, Christopher G. Chapman, Edward Villa, Benjamin Tharian, Sumant Inamdar, Joo Ha Hwang, Monique T. Barakat, Iman Andalib, Monica Gaidhane, Avik Sarkar, Haroon Shahid, Amy Tyberg, Kenneth BinmoellerRabindra R. Watson, Andrew Nett, Christoph Schlag, Mohamed Abdelhafez, Mireen Friedrich-Rust, Alexander Schlachterman, Austin L. Chiang, David Loren, Thomas Kowalski, Michel Kahaleh*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

5 Citations (Scopus)

Abstract

Background and Aims: Direct endoscopic necrosectomy (DEN) of walled-off pancreatic necrosis (WOPN) lacks dedicated instruments and requires repetitive and cumbersome procedures. This study evaluated the safety and efficacy of a new powered endoscopic debridement (PED) system designed to simultaneously resect and remove solid debris within WOPN. Methods: This was a single-arm, prospective, multicenter, international device trial conducted from November 2018 to August 2019 at 10 sites. Patients with WOPN ≥6 cm and ≤22 cm and with >30% solid debris were enrolled. The primary endpoint was safety through 21 days after the last DEN procedure. Efficacy outcomes included clearance of necrosis, procedural time, adequacy of debridement, number of procedures until resolution, hospital stay duration, and quality of life. Results: Thirty patients (mean age, 55 years; 60% men) underwent DEN with no device-related adverse events. Of 30 patients, 15 (50%) achieved complete debridement in 1 session and 20 (67%) achieved complete debridement within 2 or fewer sessions. A median of 1.5 interventions (range, 1-7) were required. Median hospital stay was 10 days (interquartile range, 22). There was an overall reduction of 91% in percent necrosis within WOPN from baseline to follow-up and 85% in collection volume. Baseline WOPN volume was positively correlated with the total number of interventions (ρ =.363, P =.049). Conclusions: The new PED system seems to be a safe and effective treatment tool for WOPN, resulting in fewer interventions and lower hospital duration when compared with published data on using conventional instruments. Randomized controlled trials comparing the PED system with conventional DEN are needed. (Clinical trial registration number: NCT03694210.)

Original languageEnglish
Pages (from-to)471-479
Number of pages9
JournalGastrointestinal Endoscopy
Volume95
Issue number3
DOIs
Publication statusPublished - 1 Mar 2022

Bibliographical note

Funding Information:
DISCLOSURE: The following authors disclosed financial relationships: M. J. Bruno: Consultant for Boston Scientific, Pentax Medical, and Cook Medical; grant support from Boston Scientific, Pentax Medical, Mylan, Interscope Med, 3M, and Cook Medical. A. Koch: Grants from Interscope and DrFalk Pharma; consultant for Pentax Medical, Boston Scientific, and ERBE Elektromedizin. A. J. Trindade: Consultant for Pentax. P. C. Benias: Consultant for Boston Scientific, Apollo Endosurgery, Fujifilm America, Creo Medical, and Olympus America. D. V. Sejpal, D. Loren: Consultant for Boston Scientific and Olympus America. U. D. Siddiqui: Consultant for Boston Scientific, ConMed, Medtronic, Cook, and Olympus America; speaker for Ovesco and Pinnacle Biologics. C. G. Chapman: Consultant for Boston Scientific, Olympus, and Apollo Endosurgery. E. Villa: Consultant for Medtronic and Olympus America. B. Tharian: Consulant for Boston Scientific, Medtronic and Olympus. J. H. Hwang: Consultant for Boston Scientific, Fujinon Medical, Medtronic, US Endoscopy, Olympus America, Microtech, and Lumendi. I. Andalib: Consultant for ConMed. M. Gaidhane: Consultant for Interscope Med; chief operating officer for Innovative Digestive Health Education & Research Inc. A. Sarkar: Consultant for US Endoscopy and Obalon Therapeutics. H. Shahid: Consultant for US Endoscopy. A. Tyberg: Consultant for EndoGastric Solutions, Boston Scientific, and Ambu Inc. K. Binmoeller: Consultant for Interscope Med. C. Schlag: Consultant for Boston Scientific, Interscope Med, Medtronic, and Olympus America. A. Schlachterman: Consultant for Lumendi, Fujifilm, Medtronic, and ConMed. A. L. Chiang: Consultant for Boston Scientific. T. Kowalski: Consultant for Boston Scientific and Medtronic. M. Kahaleh: Consultant for Boston Scientific, Interscope Med, and Abbvie; grant support from Interscope Med, Boston Scientific, Conmed, Gore, Pinnacle, Merit Medical, and Olympus Medical; founder and chief executive officer of Innovative Digestive Health Education & Research Inc. All other authors disclosed no financial relationships. Research support for this study was provided by Interscope Inc.

Funding Information:
DISCLOSURE: The following authors disclosed financial relationships: M. J. Bruno: Consultant for Boston Scientific, Pentax Medical, and Cook Medical; grant support from Boston Scientific, Pentax Medical, Mylan, Interscope Med, 3M, and Cook Medical. A. Koch: Grants from Interscope and DrFalk Pharma; consultant for Pentax Medical, Boston Scientific, and ERBE Elektromedizin. A. J. Trindade: Consultant for Pentax. P. C. Benias: Consultant for Boston Scientific, Apollo Endosurgery, Fujifilm America, Creo Medical, and Olympus America. D. V. Sejpal, D. Loren: Consultant for Boston Scientific and Olympus America. U. D. Siddiqui: Consultant for Boston Scientific, ConMed, Medtronic, Cook, and Olympus America; speaker for Ovesco and Pinnacle Biologics. C. G. Chapman: Consultant for Boston Scientific, Olympus, and Apollo Endosurgery. E. Villa: Consultant for Medtronic and Olympus America. B. Tharian: Consulant for Boston Scientific, Medtronic and Olympus. J. H. Hwang: Consultant for Boston Scientific, Fujinon Medical, Medtronic, US Endoscopy, Olympus America, Microtech, and Lumendi. I. Andalib: Consultant for ConMed. M. Gaidhane: Consultant for Interscope Med; chief operating officer for Innovative Digestive Health Education & Research Inc. A. Sarkar: Consultant for US Endoscopy and Obalon Therapeutics. H. Shahid: Consultant for US Endoscopy. A. Tyberg: Consultant for EndoGastric Solutions, Boston Scientific, and Ambu Inc. K. Binmoeller: Consultant for Interscope Med. C. Schlag: Consultant for Boston Scientific, Interscope Med, Medtronic, and Olympus America. A. Schlachterman: Consultant for Lumendi, Fujifilm, Medtronic, and ConMed. A. L. Chiang: Consultant for Boston Scientific. T. Kowalski: Consultant for Boston Scientific and Medtronic. M. Kahaleh: Consultant for Boston Scientific, Interscope Med, and Abbvie; grant support from Interscope Med, Boston Scientific, Conmed, Gore, Pinnacle, Merit Medical, and Olympus Medical; founder and chief executive officer of Innovative Digestive Health Education & Research Inc. All other authors disclosed no financial relationships. Research support for this study was provided by Interscope Inc.

Publisher Copyright:
© 2022 American Society for Gastrointestinal Endoscopy

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