Pauline M C Stassen1, Pieter Jan F de Jonge1, Marco J Bruno1, Arjun D Koch1, Arvind J Trindade2, Petros C Benias2, Divyesh V Sejpal2, Uzma D Siddiqui3, Christopher G Chapman3, Edward Villa4, Benjamin Tharian5, Sumant Inamdar5, Joo Ha Hwang6, Monique T Barakat6, Iman Andalib7, Monica Gaidhane7, Avik Sarkar7, Haroon Shahid7, Amy Tyberg7, Kenneth Binmoeller8, Rabindra R Watson8, Andrew Nett8, Christoph Schlag9, Mohamed Abdelhafez9, Mireen Friedrich-Rust10, Alexander Schlachterman11, Austin L Chiang11, David Loren11, Thomas Kowalski11, Michel Kahaleh7. 1. Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands. 2. Zucker School of Medicine at Hofstra/Northwell, Northwell Health System, Long Island Jewish Medical Center, New Hyde Park, New York, USA. 3. The Center for Endoscopic Research and Therapeutics (CERT), University of Chicago Medicine, Chicago, Illinois, USA. 4. Division of Gastroenterology and Hepatology, University of Illinois at Chicago Medical Center, Chicago, Illinois, USA. 5. Department of Internal Medicine, Division of Gastroenterology and Hepatology, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA. 6. Division of Gastroenterology and Hepatology, Stanford University Medical Center, Stanford University, Stanford, California, USA. 7. Division of Gastroenterology, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA. 8. Interventional Endoscopy Services, California Pacific Medical Center, San Francisco, California, USA. 9. Medical Department, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany. 10. Department of Internal Medicine 1, Hospital of the Goethe University Frankfurt, Frankfurt am Main, Germany. 11. Department of Gastroenterology and Hepatology, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
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.).
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.).
Authors: Mehdi Mohamadnejad; Amir Anushiravani; Amir Kasaeian; Majid Sorouri; Shirin Djalalinia; Amirmasoud Kazemzadeh Houjaghan; Monica Gaidhane; Michel Kahaleh Journal: Endosc Int Open Date: 2022-04-14
Authors: Markus Brand; Jeannine Bachmann; Christoph Schlag; Ulrich Huegle; Imdadur Rahman; Edris Wedi; Benjamin Walter; Oliver Möschler; Lukas Sturm; Alexander Meining Journal: World J Gastrointest Surg Date: 2022-08-27