• DayyehBarham K AbuBKADivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN., Vinay Chandrasekhara, Raj J Shah, Jeffrey J Easler, Andrew C Storm, Mark Topazian, Michael J Levy, John A Martin, Bret T Petersen, Naoki Takahashi, Steven Edmundowicz, Hazem Hammad, Mihir S Wagh, Sachin Wani, John DeWitt, Benjamin Bick, Mark Gromski, Al HaddadMohammadMDivision of Gastroenterology and Hepatology, indiana University School of Medicine, indianapolis, IN., Stuart Sherman, Ambreen A Merchant, Joyce A Peetermans, Ornela Gjata, Edmund McMullen, and Field F Willingham.
• Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN.
• Ann. Surg. 2023 May 1; 277 (5): e1072e1080e1072-e1080.

ObjectiveWe evaluated a protocolized endoscopic necrosectomy approach with a lumen-apposing metal stent (LAMS) in patients with large symptomatic walled-off pancreatic necrosis (WON) comprising significant necrotic content, with or without infection.Summary Background DataRandomized trials have shown similar efficacy of endoscopic treatment compared with surgery for infected WON.DesignWe conducted a regulatory, prospective, multicenter single-arm clinical trial examining the efficacy and safety of endoscopic ultrasound -guided LAMS with protocolized necrosectomy to treat symptomatic WON ≥6 cm in diameter with >30% solid necrosis. After LAMS placement, protocolized WON assessment was conducted and endoscopic necrosectomy was performed for insufficient WON size reduction and persistent symptoms. Patients with radiographic WON resolution to ≤ 3 cm and/or 60-day LAMS indwell had LAMS removal, then 6-month follow-up. Primary endpoints were probability of radiographic resolution by 60 days and procedure-related serious adverse events.ResultsForty consecutive patients were enrolled September 2018 to March 2020, of whom 27 (67.5%) were inpatients and 19 (47.5%) had clinical evidence of infection at their index procedure. Mean WON size was 15.0 ± 5.6 cm with mean 53.2% ± 16.7% solid necrosis. Radiographic WON resolution was seen in 97.5% (95% CI, 86.8%, 99.9%) by 60 days, without recurrence in 34 patients with 6-month follow-up data. Mean time to radiographic WON resolution was 34.1 ± 16.8 days. Serious adverse events occurred in 3 patients (7.5%), including sepsis, vancomycin-resistant enterococcal bacteremia and shock, and upper gastrointestinal bleeding. There were no procedure-related deaths.ConclusionsEndoscopic ultrasound-guided drainage with protocolized endoscopic necrosectomy to treat large symptomatic or infected walled-off necrotic pancreatic collections was highly effective and safe. Clinicaltrials.-gov no: NCT03525808.Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.

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