1. Combined Drainage and Protocolized Necrosectomy Through a Coaxial Lumen-apposing Metal Stent for Pancreatic Walled-off Necrosis
- Author
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Vinay Chandrasekhara, Joyce Peetermans, Hazem T. Hammad, Ambreen A. Merchant, Andrew C. Storm, Sachin Wani, Mohammad Al Haddad, Mark A. Gromski, Mihir S. Wagh, Jeffrey J. Easler, Stuart Sherman, Barham K. Abu Dayyeh, Bret T. Petersen, Edmund McMullen, John A. Martin, Field F. Willingham, John M. DeWitt, Steven A. Edmundowicz, Michael J. Levy, Mark Topazian, Ornela Gjata, Raj J. Shah, Benjamin L. Bick, and Naoki Takahashi
- Subjects
medicine.medical_specialty ,business.industry ,Multicenter trial ,medicine.medical_treatment ,Walled off necrosis ,Medicine ,Stent ,Lumen (anatomy) ,Surgery ,Drainage ,business - Abstract
We 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.Randomized trials have shown similar efficacy of endoscopic treatment compared to surgery for infected WON.We conducted a regulatory, prospective, multicenter single-arm clinical trial examining the efficacy and safety of endoscopic ultrasound (EUS)-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 (SAEs).Forty consecutive patients were enrolled September 2018 - 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. SAEs occurred in 3 patients (7.5%), including sepsis, vancomycin-resistant enterococcal bacteremia and shock, and upper gastrointestinal bleeding. There were no procedure-related deaths.EUS-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.
- Published
- 2023