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http://hdl.handle.net/2445/164368
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 Pancreatitis Necrosi Endoscopy Stents (Surgery) Pancreatitis Necrosis |
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. |
Note: | Reproducció del document publicat a: https://doi.org/10.1186/s13063-019-3988-x |
It is part of: | Trials, 2019, vol. 20, p. 791 |
URI: | http://hdl.handle.net/2445/164368 |
Related resource: | https://doi.org/10.1186/s13063-019-3988-x |
ISSN: | 1745-6215 |
Appears in Collections: | Articles publicats en revistes (Patologia i Terapèutica Experimental) Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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