Comparison Between Unilateral Versus Bilateral Stenting for Malignant Hilar Biliary Obstruction to Use a Large Cell Niti-S (LCD) Stent
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Stent patency
研究概览
简要总结
Internal biliary drainage is an useful method for a control of jaundice and cholangitis to patients who had a malignant hilar obstruction due to hepatocellular carcinoma, cholangiocarcinoma, gall bladder cancer or metastatic lymphadenopathy.
Bilateral biliary drainage is more physiologic but technically difficult to compared with unilateral biliary drainage specially related to conformability and flexibility between using stents.
There are no prospective clinical trials compared with these internal biliary drainage methods in hilar malignant obstruction using metal stent.
Therefore, the investigators want to compare the clinical outcome of two method: Unilateral biliary stent and Bilateral biliary stent
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
- •diagnosis of malignancy in pathology or cytology
- •jaundice(Total bilirubin)> 2.0 mg/dL
- •Diagnosed malignant hilar invasion to CT or other image finding
排除标准
- •bleeding tendency(INR>1.5)
- •Pregnancy
- •severe liver,kidney disease
研究组 & 干预措施
Unilateral stent insertion group
the use of unilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP)
干预措施: stent insertion (Device)
Unilateral stent insertion group
the use of unilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP)
干预措施: Endoscopic retrograde cholangiopancreatoscopy(ERCP) (Procedure)
Bilateral stent insertion group
the use of bilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP)
干预措施: stent insertion (Device)
Bilateral stent insertion group
the use of bilateral stent insertion in malignant hilar obstruction for using endoscopic retrograde cholangiopancreatography(ERCP)
干预措施: Endoscopic retrograde cholangiopancreatoscopy(ERCP) (Procedure)
结局指标
主要结局
Stent patency
时间窗: up to 1year
Participants will followed for the new obstruction(new jaundice) will occur.
次要结局
- survival period(up to 1year)
研究者
Kwang Hyuck Lee
Professor
Samsung Medical Center