Safety and efficacy of a novel resection system for direct endoscopic necrosectomy of walled-off pancreas necrosis
| Autor: | David E. Loren, Sumant Inamdar, M Abdelhafez, Mireen Friedrich-Rust, Petros C. Benias, Christoph Schlag, Arjun D. Koch, Christopher G. Chapman, Amy Tyberg, Arvind J. Trindade, Pauline M.C. Stassen, Uzma D. Siddiqui, Joo Ha Hwang, Divyesh V. Sejpal, Iman Andalib, Michel Kahaleh, Monique T. Barakat, Austin Chiang, Andrew Nett, Edward Villa, Marco J. Bruno, Alexander Schlachterman, Thomas E. Kowalski, Monica Gaidhane, Benjamin Tharian, Kenneth F. Binmoeller, Pieter J F de Jonge, Rabindra R. Watson, Avik Sarkar, Haroon Shahid |
|---|---|
| Přispěvatelé: | Gastroenterology & Hepatology |
| Jazyk: | angličtina |
| Rok vydání: | 2022 |
| Předmět: |
Male
medicine.medical_specialty SF-36 law.invention Necrosis Randomized controlled trial Quality of life law Interquartile range Multicenter trial Clinical endpoint medicine Humans Data monitoring committee Radiology Nuclear Medicine and imaging Prospective Studies Pancreas Retrospective Studies Pancreatitis Acute Necrotizing business.industry Gastroenterology Middle Aged Surgery Clinical trial Treatment Outcome Quality of Life Drainage Female Stents business |
| Zdroj: | Gastrointestinal Endoscopy, 95(3), 471-479. Mosby Inc. |
| ISSN: | 0016-5107 |
| Popis: | 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 .) |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect