AI Article Synopsis
- Lumen-apposing metal stents (LAMS) are increasingly being used for treating pancreatic-fluid collections, specifically walled-off necrosis (WON), but their effectiveness over traditional plastic stents has not yet been established.
- This study is a randomized controlled trial involving 114 patients across nine hospitals in Spain, comparing the efficacy of LAMS to plastic stents in EUS-guided transmural drainage of WON, with a focus on short-term and long-term clinical success and safety.
- The goal of the PROMETHEUS trial is to provide clear evidence on whether LAMS provide superior treatment outcomes compared to plastic stents for patients with WON.
Article 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.
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Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6937819 | PMC |
| http://dx.doi.org/10.1186/s13063-019-3988-x | DOI Listing |
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