Multicenter, Randomized and Comparative Study of Lumen-apposing Metal Stents With or Without Coaxial Plastic Stent for Endoscopic Ultrasound-guided Transmural Biliary Drainage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- Recurrent biliary obstruction (RBO)
研究概览
简要总结
The aim of the study is to evaluate technical, clinical and safety outcomes of lumen-apposing metal stent (LAMS) with and without a coaxial double-pigtail plastic stent (DPS) in EUS-guided choledochoduodenostomies (CDS) for the management of biliary obstruction.
详细描述
The introduction of specific biliary lumen-apposing metal stents (LAMS) represented a great technical improvement in EUS-guided transmural Biliary drainage (BD) of distal malignant biliary obstruction Data is still limited, but recent studies and reviews have been reported with acceptable technical and clinical success. However, some concerns exist regarding its safety, as secondary adverse events
There are doubts concerning the possible benefits derived from the insertion of double-pigtail plastic stents (DPS) within the lumen-apposing metal stents (LAMS) in the EUS-guided choledochoduodenostomy (CDS). Our hypothesis is that adding a coaxial plastic stent may offer benefits in terms of safety in CDS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Distal biliary strictures,
- •A prior failed attempt at biliary drainage
- •informed consent provided by the patient.
排除标准
- •were as follows:
- •younger than age 18 years,
- •coagulopathy (international normalized ratio >1.5, marked thrombocytopenia with a platelet count <50,000/mL, or patient on anticoagulation therapy),
- •critical illness.
结局指标
主要结局
Recurrent biliary obstruction (RBO)
时间窗: 12 months
Recurrent biliary obstruction (RBO) has been defined as a composite endpoint of either occlusion or migration.
Safety (Adverse events)
时间窗: 12 months
Safety will be measured by careful and comparative evaluation of adverse effects in both groups.
次要结局
- Survival(12 months)
- Clinical success(2 weeks)
- Technical success(24 hours.)
研究者
Joan B Gornals
Head of Interventional Digestive Endoscopy Unit.
Hospital Universitari de Bellvitge