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Multicenter study of plastic vs. self-expanding metal stents in endoscopic ultrasound-guided drainage of walled-off pancreatic necrosis - PROMETHEUS: a randomized controlled trial protocol.

ABSTRACT: 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

SUBMITTER: Gornals JB 

PROVIDER: S-EPMC6937819 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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<h4>Background</h4>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.<h4>Methods/design</h4>This is a randomized controlled, multicenter, prospective clinical trial with two parallel groups, without masking. One-h  ...[more]

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