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

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...

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Published in:Gastrointestinal endoscopy 2022-03, Vol.95 (3), p.471-479
Main Authors: Stassen, Pauline M.C., de Jonge, Pieter Jan F., Bruno, Marco J., Koch, Arjun D., Trindade, Arvind J., Benias, Petros C., Sejpal, Divyesh V., Siddiqui, Uzma D., Chapman, Christopher G., Villa, Edward, Tharian, Benjamin, Inamdar, Sumant, Hwang, Joo Ha, Barakat, Monique T., Andalib, Iman, Gaidhane, Monica, Sarkar, Avik, Shahid, Haroon, Tyberg, Amy, Binmoeller, Kenneth, Watson, Rabindra R., Nett, Andrew, Schlag, Christoph, Abdelhafez, Mohamed, Friedrich-Rust, Mireen, Schlachterman, Alexander, Chiang, Austin L., Loren, David, Kowalski, Thomas, Kahaleh, Michel
Format: Article
Language:English
Subjects:
Drainage - methods
Female
Humans
Male
Middle Aged
Necrosis - surgery
Pancreas - surgery
Pancreatitis, Acute Necrotizing - surgery
Prospective Studies
Quality of Life
Retrospective Studies
Stents
Treatment Outcome
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Summary: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. 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. 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). 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.) [Display omitted]
ISSN:0016-5107
1097-6779
DOI:10.1016/j.gie.2021.09.025