A Comparison of a Fully Covered Self-expandable Metal Stent With an External Anchoring Plastic Stent and Uncovered Stent: Prospective Randomized Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Rate of patent stent
研究概览
简要总结
Multi-center, randomized controlled study fc-SEMS with anchoring plastic stent vs uc-SEMS in malignant biliary obstruction
详细描述
This study is multi-center, randomized controlled study to compare the stent patency in malignant biliary obstruction. The patency of fully covered self expandable metal stent with external anchoring plastic stent was compared with that of uncovered self expandable metal 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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with 19 years of age or older
- •Those who voluntarily consented to the trial and signed a written consent
- •Inoperable malignant biliary obstruction
排除标准
- •Previous surgical biliary drainage
- •Patients continuosly requiring percutaneous transhepatic biliary drainage
- •History of biliary drainage with metal stent
- •Biliary obstruction located in hilum or intrahepatic duct
- •Patients with life expectancy of 3 months or less
- •On pregnancy
- •Unable to underwent endoscopic procedures
研究组 & 干预措施
uc-SEMS
uncovered self-expandable metal stent
干预措施: uncovered self-expandable metal stent (Device)
fc-SEMS with anchoring plastic stent
fully covered self-expanable metal stent with an external anchoring plastic stent
干预措施: fully covered self-expandable metal stent with an anchoring external plastic stent (Device)
结局指标
主要结局
Rate of patent stent
时间窗: 1 year
The number of patient without stent dysfuction divided by total number of patients
次要结局
- Adverse event(1 year)
- Stent migration(1 year)
- Stent obstruction(1 year)
- Overall survival(1 year)
- Re-intervention(1 year)
研究者
Sang Hyub Lee
Professor
Seoul National University Hospital