Efficacy and Safety of a Fully Covered Self-Expandable Metal Stent for Unresectable Hepatocellular Carcinoma: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Clinical success rate
研究概览
简要总结
The effectiveness and safety of fully covered metal stent in malignant biliary obstruction caused by HCC are still unknown. These would be clarified in this prospective cohort study.
详细描述
In this study, endoscopic biliary drainage was performed using fully covered self-expancdable metal stent for malignant biliary obstruction caused by HCC. Main outcome is efficacy and safety of this procedure including clinical success rate, technical success rate, stent patency, stent dysfunction, and any adverse events during the follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 years or older, those who consented to the clinical research participation and signed a written consent form
- •Obstructive jaundice caused by unresectable hepatocellular carcinoma
排除标准
- •Patients who have previously undergone surgical biliary drainage
- •Patients who need to remain percutaneous transhepatic biliary drainage
- •Patients whose life expectancy is less than 3 months (BCLC stage D without a treatment plan for hepatocellular carcinoma)
- •Patients who cannot undergo endoscopic procedure according to the judgment of the researcher
结局指标
主要结局
Clinical success rate
时间窗: 1 month
Clinical success rate is defined as a reduction of total bilirubin level above 50% or total bilirubin level less than 2 mg/dL within 1 month after the procedure. Clinical success rate of all procedures will be measured.
Technical success rate
时间窗: 1 day
Technical success is defined as whether the stent is properly inserted into the stricture site and the bile or contrast agent is drained. Technical success rate of all procedures will be measured.
次要结局
- Stent patency duration(1 year)
- Stent migration rate(1 year)
- Stent dysfunction rate(1 year)
研究者
Sang Hyub Lee
Professor
Seoul National University Hospital