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Background: It seems that lumen-apposing metal stents (LAMS) are displacing plastic stents in the therapy of pancreatic-fluid collection in walled-off necrosis (WON). To date, there is no quality of evidence to recommend LAMS as the standard treatment in the management of WON. The theoretical benefit of LAMS over plastic stents needs to be proven.Methods/design: This is a randomized controlled, multicenter, prospective clinical trial with two parallel groups, without masking. One-hundred and fourteen patients with WON will undergo endoscopic ultrasound (EUS)-guided transmural draining in nine tertiary hospitals in Spain and will be randomized to the LAMS or plastic-stent group. The primary endpoint is the short-term (4 weeks) clinical success determined by the reduction of the collection (to < 50% or < 5 cm in size), along with clinical improvement. Secondary endpoints: long-term (4 months) clinical success (total resolution or 5 cm), procedure duration, level of difficulty, safety, and recurrences.Discussion: The PROMETHEUS trial has been designed to determine whether LAMS are superior to plastic stents in EUS-guided transmural drainage of WON.Trial Registration: ClinicalTrials.gov, ID: NCT03100578. Registered on 4 April 2017. https://clinicaltrials.gov/ct2/home. [ABSTRACT FROM AUTHOR]

Background and study aims: A novel large-diameter, lumen-apposing, self-expanding metal stent with bilateral flanges was recently developed for endoscopic ultrasound (EUS)-guided transmural drainage of symptomatic pancreatic fluid collections (PFCs). The aim of this study was to evaluate the efficacy and safety of this stent in a large cohort. Patients and methods: Patients with a PFC undergoing EUS-guided drainage with this novel stent were prospectively enrolled in this multicenter cohort study. Results: There were 61 patients: 46 patients (75 %) with walled-off necrosis(WON) and 15 (25 %) with a pancreatic pseudocyst. Stent placement was technically successful in 60 patients (98 %, 95%CI 95%-100%). Clinical success, defined as resolution of clinical symptoms in combination with a decrease in the PFC size to ⩽2cm on imaging, was achieved in 93% of patients with a pancreatic pseudocyst (95 %CI 77%-100%) and in 81% of patients with WON (95 %CI 69%-94%). Treatment failure occurred in nine patients (16 %, 95%CI 6%- 26%), including four patients who required surgical intervention. Stent removal was performed in 82% of patients after a median of 32 days (range 2-178) and was rated as easy in all but one patient. In 10 patients, endoscopic stent removal was not performed because of stent migration (n=3), stent dislodgement during necrosectomy (n=3), stent removal during surgery (n=2), or refusal by the patient (n=2). In total, five major complications were reported (9 %, 95%CI 2%-16 %), including PFC infection (n=4) and perforation (n=1). Conclusion: EUS-guided drainage using this novel stent is feasible and the clinical results obtained are promising with a low major complication rate. [ABSTRACT FROM AUTHOR]