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

Autor: Stassen PMC; Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands., de Jonge PJF; Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands., Bruno MJ; Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands., Koch AD; Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands., Trindade AJ; Zucker School of Medicine at Hofstra/Northwell, Northwell Health System, Long Island Jewish Medical Center, New Hyde Park, New York, USA., Benias PC; Zucker School of Medicine at Hofstra/Northwell, Northwell Health System, Long Island Jewish Medical Center, New Hyde Park, New York, USA., Sejpal DV; Zucker School of Medicine at Hofstra/Northwell, Northwell Health System, Long Island Jewish Medical Center, New Hyde Park, New York, USA., Siddiqui UD; The Center for Endoscopic Research and Therapeutics (CERT), University of Chicago Medicine, Chicago, Illinois, USA., Chapman CG; The Center for Endoscopic Research and Therapeutics (CERT), University of Chicago Medicine, Chicago, Illinois, USA., Villa E; Division of Gastroenterology and Hepatology, University of Illinois at Chicago Medical Center, Chicago, Illinois, USA., Tharian B; Department of Internal Medicine, Division of Gastroenterology and Hepatology, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA., Inamdar S; Department of Internal Medicine, Division of Gastroenterology and Hepatology, University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA., Hwang JH; Division of Gastroenterology and Hepatology, Stanford University Medical Center, Stanford University, Stanford, California, USA., Barakat MT; Division of Gastroenterology and Hepatology, Stanford University Medical Center, Stanford University, Stanford, California, USA., Andalib I; Division of Gastroenterology, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA., Gaidhane M; Division of Gastroenterology, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA., Sarkar A; Division of Gastroenterology, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA., Shahid H; Division of Gastroenterology, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA., Tyberg A; Division of Gastroenterology, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA., Binmoeller K; Interventional Endoscopy Services, California Pacific Medical Center, San Francisco, California, USA., Watson RR; Interventional Endoscopy Services, California Pacific Medical Center, San Francisco, California, USA., Nett A; Interventional Endoscopy Services, California Pacific Medical Center, San Francisco, California, USA., Schlag C; Medical Department, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany., Abdelhafez M; Medical Department, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany., Friedrich-Rust M; Department of Internal Medicine 1, Hospital of the Goethe University Frankfurt, Frankfurt am Main, Germany., Schlachterman A; Department of Gastroenterology and Hepatology, Thomas Jefferson University, Philadelphia, Pennsylvania, USA., Chiang AL; Department of Gastroenterology and Hepatology, Thomas Jefferson University, Philadelphia, Pennsylvania, USA., Loren D; Department of Gastroenterology and Hepatology, Thomas Jefferson University, Philadelphia, Pennsylvania, USA., Kowalski T; Department of Gastroenterology and Hepatology, Thomas Jefferson University, Philadelphia, Pennsylvania, USA., Kahaleh M; Division of Gastroenterology, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA.
Jazyk: angličtina
Zdroj: Gastrointestinal endoscopy [Gastrointest Endosc] 2022 Mar; Vol. 95 (3), pp. 471-479. Date of Electronic Publication: 2021 Sep 22.
DOI: 10.1016/j.gie.2021.09.025
Abstrakt: 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.).
(Copyright © 2022 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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