Multicenter Study Of Plastic Vs. Self-expanding Metal Stents In Endoscopic Ultrasound-drainage Of Walled-off Pancreatic Necrosis – Prometheus: A Randomised Controlled Trial Protocol

Autor: joan b gornals, Manuel Perez-Miranda, Enrique Vazquez-Sequeiros, Juan Vila, Jose M Esteban, Ferran Gonzalez-Huix, Carlos Guarner-Argente, Andres Sanchez-Yague, Alvaro Teran, Francesc Bas-Cutrina, Carlos De La Serna, Ana Garcia Garcia De Paredes, Raquel Ballester, Julio Velasquez-Rodriguez, Silvia Salord, Cristian Tebe, Pilar Hereu, Sebastia Videla
Rok vydání: 2019
DOI: 10.21203/rs.2.16362/v2
Popis: Background: It seems that the appearance of lumen-apposing metal stents (LAMS), are displacing the role of plastic stents in the therapy of pancreatic fluid collection as walled-off necrosis (WON). To date there is no quality of evidence to recommend LAMS as the standard treatment in management of WON. The theoretical benefit of LAMS over PLASTIC stents, need to be proved. Methods/design: This is a multicenter prospective study, superiority, randomized controlled clinical trial by parallel groups, without masking. One hundred fourteen patients with WON will be Endoscopic ultrasound (EUS)-guided transmural drained in 9 tertiary hospitals in Spain and will be randomized to the LAMS or PLASTIC stent group. The primary endpoint is to assess the short-term (4 weeks) clinical success determined by the reduction of the collection (to
Databáze: OpenAIRE