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

Abstract

KEYWORDSEndoscopic ultrasound, lumen apposing metal stent, metal self-expanding stent, plastic stent, trial, walled-off necrosis 3 Abstract 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 <50% or < 5cm in size), along with clinical improvement. Secondary endpoints: the long-term (4 months) clinical success (total resolution or 5cm); the procedure's duration, the level of difficulty, safety and recurrences.Discussion: The PROMETHEUS trial has been designed to response if LAMS are superior over PLASTIC stents in the EUS-guided transmural drainage of WON.