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Background: Lumen-apposing metal stents (LAMS) have displaced double-pigtail plastic stents (DPS) as the standard treatment for walled-off necrosis (WON),β but evidence for exclusively using LAMS is limited. We aimed to assess whether the theoretical benefit of LAMS was superior to DPS. Methods: This multicenter, open-label, randomized trial was carried out in 9 tertiary hospitals. Between June 2017, and Oct 2020, we screened 99 patients with symptomatic WON, of whom 64 were enrolled and randomly assigned to the DPS group (n= 31) or the LAMS group (n= 33). The primary outcome was short-term (4-weeks) clinical success determined by the reduction of collection. Secondary endpoints included long-term clinical success, hospitalization, procedure duration, recurrence, safety, and costs. Analyses were by intention-to-treat. ClinicalTrials.gov, NCT03100578. Results: A similar clinical success rate in the short term (RR, 1.41; 95% CI 0.88–2.25; p= 0.218) and in the long term (RR, 1.2; 95% CI 0.92–1.58; p= 0.291) was observed between both groups. Procedure duration was significantly shorter in the LAMS group (35 vs. 45-min, p= 0.003). The hospital admission after the index procedure (median difference, − 10 [95% CI − 17.5, − 1]; p= 0.077) and global hospitalization (median difference − 4 [95% CI − 33, 25.51]; p= 0.82) were similar between both groups. Reported stent-related adverse events were similar for the two groups (36 vs.45% in LAMS vs. DPS), except for de novo fever, which was significantly 26% lower in LAMS (RR, 0.26 [0.08–0.83], p= 0.015). Conclusions: The clinical superiority of LAMS over DPS for WON therapy was not proved, with similar clinical success, hospital stay and similar safety profile between both groups, yet a significant reduction in procedure time was observed. Trial registration number: ClinicalTrials.gov, NCT03100578. Graphical abstract:

Endoscopic management of walled-off pancreatic necrosis (WOPN) is an area of great interest with many still unanswered questions, including the role of mechanical necrosectomy versus irrigation. The aim of this study was to evaluate a new method of endoscopic transmural necrosectomy. Patients with WOPN after necrotizing pancreatitis, who underwent endoscopic transmural necrosectomy using a lumen-apposing metal stent with vigorous irrigation sessions, were prospectively recruited between September 2011 and August 2014. Initial endoscopic session was performed by EUS-guided drainage and lavage sessions by flushing saline through the stent. Technical and clinical success rates, number of repeat interventions, and adverse events were analyzed. Twelve patients with 13 WOPN collections (median size 12.4 ± 2.94 cm) underwent endoscopic treatment. Clinical success was achieved in 100 % of cases after a median of three sessions per patient (range 2–8). The median length of hospitalization was 15.9 days. Median procedure time of the access session was 31 ± 10.16 min. No adverse events (AE) were described during the procedures or 24 h after. There were four AE (two infections and two bleedings) between sessions, but only two were severe (16.6 %). There was no need for surgery, and no mortalities occurred. Mean time to stent retrieval was 9 ± 3.4 weeks. Mean follow-up was 13 months with only one recurrence at 12 months after stent removal. This new variant of irrigation endoscopic transmural necrosectomy without mechanical debridement helps to simplify the technique, is feasible, and has excellent outcomes in WOPN treatment.