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Title: 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.
Author: Gornals Soler, Joan B.
Perez-Miranda, Manuel
Vazquez-Sequeiros, Enrique
Vila, Juan
Esteban, José M.
Gonzalez-Huix, Ferran
Guarner-Argente, Carlos
Sánchez Yagüe, Andrés
Teran, Alvaro
Bas-Cutrina, Francesc
De La Serna, Carlos
Garcia De Paredes, Ana
Ballester, Raquel
Velasquez-Rodriguez, Julio
Salord, Silvia
Tebé, Cristian
Hereu, Pilar
Videla, Sebas
Spanish Working Group on Pancreatic Collection Therapy
Keywords: Endoscòpia
Pròtesis de Stent
Stents (Surgery)
Issue Date: 30-Dec-2019
Publisher: BioMed Central
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 < 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.
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It is part of: Trials, 2019, vol. 20, p. 791
Related resource:
ISSN: 1745-6215
Appears in Collections:Articles publicats en revistes (Patologia i Terapèutica Experimental)

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