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

      Graphical abstract

      Figure thumbnail fx1
      Graphical Abstract

      Abbreviations:

      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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      Article info

      Publication history

      Published online: September 22, 2021
      Accepted: September 10, 2021
      Received: July 9, 2021

      Footnotes

      DISCLOSURE: The following authors disclosed financial relationships: M. J. Bruno: Consultant for Boston Scientific, Pentax Medical, and Cook Medical; grant support from Boston Scientific, Pentax Medical, Mylan, Interscope Med, 3M, and Cook Medical. A. Koch: Grants from Interscope and DrFalk Pharma; consultant for Pentax Medical, Boston Scientific, and ERBE Elektromedizin. A. J. Trindade: Consultant for Pentax. P. C. Benias: Consultant for Boston Scientific, Apollo Endosurgery, Fujifilm America, Creo Medical, and Olympus America. D. V. Sejpal, D. Loren: Consultant for Boston Scientific and Olympus America. U. D. Siddiqui: Consultant for Boston Scientific, ConMed, Medtronic, Cook, and Olympus America; speaker for Ovesco and Pinnacle Biologics. C. G. Chapman: Consultant for Boston Scientific, Olympus, and Apollo Endosurgery. E. Villa: Consultant for Medtronic and Olympus America. B. Tharian: Consulant for Boston Scientific, Medtronic and Olympus. J. H. Hwang: Consultant for Boston Scientific, Fujinon Medical, Medtronic, US Endoscopy, Olympus America, Microtech, and Lumendi. I. Andalib: Consultant for ConMed. M. Gaidhane: Consultant for Interscope Med; chief operating officer for Innovative Digestive Health Education & Research Inc. A. Sarkar: Consultant for US Endoscopy and Obalon Therapeutics. H. Shahid: Consultant for US Endoscopy. A. Tyberg: Consultant for EndoGastric Solutions, Boston Scientific, and Ambu Inc. K. Binmoeller: Consultant for Interscope Med. C. Schlag: Consultant for Boston Scientific, Interscope Med, Medtronic, and Olympus America. A. Schlachterman: Consultant for Lumendi, Fujifilm, Medtronic, and ConMed. A. L. Chiang: Consultant for Boston Scientific. T. Kowalski: Consultant for Boston Scientific and Medtronic. M. Kahaleh: Consultant for Boston Scientific, Interscope Med, and Abbvie; grant support from Interscope Med, Boston Scientific, Conmed, Gore, Pinnacle, Merit Medical, and Olympus Medical; founder and chief executive officer of Innovative Digestive Health Education & Research Inc. All other authors disclosed no financial relationships. Research support for this study was provided by Interscope Inc.

      See CME section, p. 582.

      DIVERSITY, EQUITY, AND INCLUSION: One or more of the authors of this article self-identifies as an under-represented gender minority in science. One or more of the authors of this article self-identifies as a member of the LGBTQ+ community. The author list of this article includes contributors from the location where the research was conducted who participated in the data collection, design, analysis, and/or interpretation of the work.

      Identification

      DOI: https://doi.org/10.1016/j.gie.2021.09.025

      Copyright

      © 2022 by the American Society for Gastrointestinal Endoscopy

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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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