Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), University of Barcelona, Feixa Llarga s/n, 08907 L'Hospitalet de Llobregat, Barcelona, Catalonia, Spain.
Health Sciences, Universitat Oberta de Catalunya, Barcelona, Spain.
Trials. 2019 Dec 30;20(1):791. doi: 10.1186/s13063-019-3988-x.
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.
The PROMETHEUS trial has been designed to determine whether LAMS are superior to plastic stents in EUS-guided transmural drainage of WON.
ClinicalTrials.gov, ID: NCT03100578. Registered on 4 April 2017. https://clinicaltrials.gov/ct2/home.
似乎 lumen-apposing 金属支架（LAMS）正在取代塑料支架，用于治疗隔离坏死（WON）中的胰液积聚。迄今为止，尚无证据质量推荐 LAMS 作为 WON 管理的标准治疗方法。需要证明 LAMS 相对于塑料支架的理论优势。
方法/设计：这是一项随机对照、多中心、前瞻性临床试验，分为两个平行组，不设盲法。西班牙 9 家三级医院的 114 例 WON 患者将接受内镜超声（EUS）引导下经壁引流，并随机分为 LAMS 或塑料支架组。主要终点是短期（4 周）临床成功率，通过减少积聚（<50%或<5cm 大小）和临床改善来确定。次要终点：长期（4 个月）临床成功率（完全缓解或<5cm）、手术时间、难度级别、安全性和复发率。
PROMETHEUS 试验旨在确定 LAMS 是否优于 EUS 引导下经壁引流 WON 中的塑料支架。
ClinicalTrials.gov，ID：NCT03100578。注册于 2017 年 4 月 4 日。https://clinicaltrials.gov/ct2/home.
