*No differences in the incidence of infection or other events 500 mg bid (3 days) 200 mg iv (1 dose) • Infection after EUS-FNA is low • The use of antibiotic prophylaxis is conflicting Antibiotic Prophylaxis is Not Needed for EUS-guided FNA of Pancreatic Cystic Lesions: a Clinical Trial Results: • Non-inferiority multicenter clinical trial 226 iv (1 dose) bid (3 days) 112 ciprofloxacin 0 (0%) 2 (1.78%) 6 (5.4%) Infection Fever Other events 114 placebo 1 (0.87%) 2 (1.76%) 8 (7%)

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BackgroundIt 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/designThis 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.DiscussionThe PROMETHEUS trial has been designed to determine whether LAMS are superior to plastic stents in EUS-guided transmural drainage of WON.Trial registrationClinicalTrials.gov, ID: NCT03100578. Registered on 4 April 2017. https://clinicaltrials.gov/ct2/home

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

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.