NCT01421836已完成2 期
Prospective Study Comparing EUS Guided Biliary Drainage and ERCP With Stent Placement for Malignant Biliary Obstruction
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- stent patency (days)
研究概览
简要总结
- Purpose of the study
-To compare stent patency and complication rate between endoscopic ultrasound (EUS) guided stent insertion and endoscopic retrograde cholangiopancreatography (ERCP) guided stent insertion for malignant biliary obstruction 2. Subjects of the study
-Patients who have biliary obstruction owing to malignant tumors 3. Methods of the study
- Prospective randomized controlled study
- Patients were enrolled randomly in two groups, EUS guided stent insertion group or ERCP guided stent insertion group
- Patients will get assigned procedure (EUS guided stent insertion or ERCP guided stent insertion)for decompression of malignant biliary obstruction
- After the procedure, regular follow up, blood test,and imaging test will be done to check sufficient biliary decompression,stent patency and complications.
详细描述
- Inclusion criteria 1) age: 18 - 80 2) a patients who had common bile duct dilatation because of malignant distal common bile duct obstruction in radiologically 3) Hyperbilirubinemia (total bilirubin >= 1.5 mg/dl) 4) inoperable state 5) a patients who agree to join this study
- Exclusion criteria 1) a patients who can not endure sedation 2) a patients with bleeding tendency (PT > 1.5 INR, PLT < 50,000) 3) a patients with systemic infection 4) a patients who had hilar obstruction
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
- 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 obstruction due to malignant tumor
- •unresectable tumor
排除标准
- •Hilar obstruction
- •Active infection
- •Bleeding tendency
结局指标
主要结局
stent patency (days)
时间窗: six months
次要结局
- complication rate(six months)
研究者
Kwang Hyuck Lee
Professor of Department of Medicine,Samsung Medical Center,Sungkyunkwan University School of Medicine
Samsung Medical Center
研究点 (2)
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