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

Joan B Gornals, Manuel Perez-Miranda, Enrique Vazquez-Sequeiros, Juan Vila, José M Esteban, Ferran Gonzalez-Huix, Carlos Guarner-Argente, Andres Sanchez-Yague, Alvaro Teran, Francesc Bas-Cutrina, Carlos De La Serna, Ana Garcia De Paredes, Raquel Ballester, Julio Velasquez-Rodriguez, Silvia Salord, Cristian Tebe, Pilar Hereu, Sebas Videla, Spanish Working Group on Pancreatic Collection Therapy, Joan B Gornals, Manuel Perez-Miranda, Enrique Vazquez-Sequeiros, Juan Vila, José M Esteban, Ferran Gonzalez-Huix, Carlos Guarner-Argente, Andres Sanchez-Yague, Alvaro Teran, Francesc Bas-Cutrina, Carlos De La Serna, Ana Garcia De Paredes, Raquel Ballester, Julio Velasquez-Rodriguez, Silvia Salord, Cristian Tebe, Pilar Hereu, Sebas Videla, Spanish Working Group on Pancreatic Collection Therapy

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.

Trial registration: ClinicalTrials.gov, ID: NCT03100578. Registered on 4 April 2017. https://clinicaltrials.gov/ct2/home.

Keywords: Endoscopic ultrasound; Lumen-apposing metal stent; Metal self-expanding stent; Plastic stent; Randomized clinical trial; Trial; Walled-off necrosis, self-expanding metal stent.

Conflict of interest statement

M Pérez-Miranda is consultant and speaker for Medtronic, Olympus, Taewoong, and MI-Tech

E Vazquez-Sequeiros is a consultant for Boston Scientific

F Gonzalez-Huix is a consultant for Boston Scientific

JB Gornals is a consultant for Boston Scientific and has received a research grant from Boston Scientific

The other authors declare that they have no competing interests.

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Source: PubMed

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