jRCTs042220149招募中不适用
A randomized controlled trial comparing ERCP-BD versus EUS-HGAS as the first line palliative drainage for malignant biliary obstruction
未提供0 个研究点目标入组 46 人开始时间: 2023年3月16日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 46
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •(1) the presence of a malignant obstruction (=>2cm distal to the hilum)
- •(2) a malignant biliary obstruction with pathologic or radiologic diagnosis
- •(3) the statement of unresectable comfarmed by radiologic diagnosis or characteristics of patient (comorbidities or age)
- •(4) Jaundice: serum total bilirubin =>2.0mg/dL or liver damage: at least 2 of liver
- •enzymes (AST, ALT, ALP, or gamma-GTP) at least 2 times above the upper limit of
- •(5) Eastern Cooperative Oncology Group performance status 0-2
- •(6) age =>18 years old
排除标准
- •(1) a hilar biliary obstruction classificated Bismuth II or more
- •(2) surgically altered anatomy of the stomach and the duodenum except Billroth I
- •(3) history of choledochojejunostomy
- •(4) vomiting and duodenal obstruction with radiologic diagnosis
- •(5) previously performed duodenal stenting
- •(6) less diameter of left intrahepatic bile duct (=<2mm)
- •(7) plateler count <50000 or prothrombin time international normalized ratio =>1.5
- •(8) impossibility in discontinuation of antithrombotic therapy
- •(9) the presence of massive ascites
- •(10) life expectancy less than 3 months
- •(11) other reasons for unsuitable statement to participate the study judged from principal investigator
结局指标
主要结局
-
TRBO (Time to recurrent biliary obsturuction)
次要结局
- adverse events
- cost of biliary drainage
- rates of peritonitis and stent migration