Abstract
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
Highlights
It seems that lumen-apposing metal stents (LAMS) are displacing plastic stents in the therapy of pancreatic-fluid collection in walled-off necrosis (WON)
The PROMETHEUS trial has been designed to determine whether LAMS are superior to plastic stents in endoscopic ultrasound (EUS)-guided transmural drainage of WON
Central ethical approval of the study protocol has been confirmed from the Comité Ético de Investigación Clínica (CEIC) del Hospital Universitari de BellvitgeIDIBELL and we will not begin recruiting at other centers in the trial until local ethical approval has been obtained
Summary
Open surgical necrosectomy has been the traditional treatment of choice in patients with infected or symptomatic pancreatic necrosis, other minimally invasive techniques have been developed in recent years (endoscopic necrosectomy, guided radiological percutaneous drainage, and retroperitoneal treatment) for treating collections, so as to improve on the high morbidity and mortality rates of traditional surgical treatment [3, 21,22,23]. Main amendments: (1) to clarify the second inclusion criterion – in case of more than one collection, the EUS-guided drainage will be limited to only one pancreatic collection (WON), related to the symptomatology (Table 2); (2) addition of the “Research product security surveillance” section, according to the definitions set out in the MEDDEV 2.7/3 guidelines (rev 3, May 2015) “Guidelines on medical devices: Clinical investigations: Serious Adverse event reporting under Directives 90/385/EECC and 93/ 42/EEC” (Additional file 2); (3) extension to nine centers with respect to the initial protocol (four centers); (4) procedural technique, rescue section: in case of failure, adding of the possibility of a “Technical variant” in LAMS group – an insertion of coaxial plastic pigtail within the metal stent Additional changes: (1) addition of new and relevant references; change of the grading of the AE classification (immediate, early, and late); (2) commercial name of each stent; (3) start delayed, from the beginning of 2016 to June 2017; (4) procedural technique section: additional comments regarding when and how some technical variants can be made; and technical notes about necrosectomy technique; (5) data management paragraph in the statistical section; and (6) telephone call at 7 days, and additional new legend explaining the possibility of a second imaging procedure at 8 weeks, only in case of radiological clinical success but with persistence of the collection > 5 cm (Table 4, Timeline) c- PROMETHEUS, June 2018, amendment n°2: version 2.1 – definitive Minor changes: addition of a new size of LAMS (20 mm in diameter). AEMPS and CEIC have been notified after every amendment, with acceptance by each institution
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