EUS-guided Biliary Drainage of First Intent With the Lumen Apposing Metal Stent vs. ERCP in the Management of Malignant Distal Biliary Obstruction: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 15
- 主要终点
- Rate of re-intervention
研究概览
简要总结
Endoscopic ultrasound guided biliary drainage (EUS-BD) is an evolving field that has grown in popularity in the management of malignant biliary obstruction. Although Endoscopic retrograde cholangio-pancreatography (ERCP) with stent insertion has been the mainstay therapy throughout several decades, the transpapillary approach through tumor tissue is associated with significant risk for adverse events such as post-ERCP pancreatitis and stent dysfunction from tumor tissue overgrowth and ingrowth. EUS-BD, through the creation of a choledochoduodenostomy with a stent, has the potential advantage of avoiding the papilla and its associated complications while potentially improving stent patency with lower risks for tumor tissue ingrowth and/or overgrowth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Radiological diagnosis (with or without pathological diagnosis) of borderline resectable, locally advanced, or unresectable malignant distal biliary obstruction at least 2 cm distal to the hilum. Resectability based on tumor staging on axial imaging and surgeon evaluation.
- •Elevated liver tests with serum bilirubin at least 3 times above the upper limit of normal (18.9 umol/L)
- •Dilated extra-hepatic bile duct measuring at least 1.2 cm on axial imaging or US
- •Confirmation of bile duct accessibility and size of at least 1.2 cm on endoscopic ultrasound
- •Karnofsky index > 30%
- •ASA score <IV
- •Provision of informed consent
排除标准
- •Hilar obstruction (biliary obstruction < 2 cm from the hilum)
- •Uncorrectable coagulopathy and/or thrombocytopenia
- •Age < 18
- •Liver metastasis involving > 30% of the liver volume
- •Liver cirrhosis with portal hypertension or ascites
- •Prior biliary sphincterotomy or stent placement
- •Surgically altered anatomy
- •Common bile duct measuring less than 1.2 cm will be excluded
- •Patient with clinical and radiological evidence of gastric outlet obstruction
结局指标
主要结局
Rate of re-intervention
时间窗: 1 year
Obstruction and/or migration of stent
次要结局
- Stent patency(1 year)
- Clinical success(1 year)
- Technical success(1 year)
- Early adverse events(1 year)
研究者
Yen-I Chen
Primary Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre