Original article Clinical endoscopy| Volume 95, ISSUE 3, P471-479, March 2022

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

Published:September 22, 2021DOI:https://doi.org/10.1016/j.gie.2021.09.025

      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.


      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.)

      Graphical abstract


      AE (adverse event), CECT (contrast-enhanced CT), DEN (direct endoscopic necrosectomy), DPS (double-pigtail stent), DSMB (data safety monitoring board), IQR (interquartile range), LAMS (lumen-apposing metal stent), PED (powered endoscopic debridement), SAE (serious adverse event), SD (standard deviation), SEMS (self-expandable metal stent), SF-36 (36-Item Short Form Survey), WOPN (walled-off pancreatic necrosis)
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      Linked Article

      • “EndoRotoring” the pancreatic necrosis: Is an old trick the answer for more effective endoscopic debridement?
        Gastrointestinal EndoscopyVol. 95Issue 3
        • Preview
          Walled-off pancreatic necrosis (WOPN) is a well-recognized subacute adverse event (AE) of acute necrotizing pancreatitis, and the term describes a collection with a mature wall that has encapsulated itself and includes variable amounts of pancreatic juice and solid necrotic debris. WOPN often requires close multidisciplinary and expert management because of the associated morbidity. Drainage of the collection by endoscopic, surgical, or percutaneous routes remains the most effective remedy for symptomatic and infected WOPNs.
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