Comparison Between Fully Covered and Partially Covered Self-expandable Metal Stents With Anti-migration System for Malignant Distal Biliary Obstruction
试验速览
- 阶段
- 不适用
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- duration of stent patency
研究概览
简要总结
The purpose of this study is to compare the duration of stent patency between partially covered and fully covered SEMS for palliation of malignant distal bile duct obstruction.
详细描述
Endoscopic stent placement has been used as a principle palliative method in patients with unresectable distal malignancy biliary obstruction. It has been pivotal in providing relief from obstructive jaundice, improving the quality of life, and allowing the maintenance of chemotherapy. Although SEMSs have been reported to be superior to plastic stents in terms of stent patency, they still have some debatable issues ; in uncovered SEMS, stent occlusion due to epithelial hyperplasia and tumor ingrowth through the metal mesh is a frequent problem, whereas covered SEMSs are prone to migration.
The aim of the current study is to compare the duration of stent patency between partially covered and fully covered SEMS as a primary objective, and investigate overall patient survival, stent occlusion rate, and incidence of adverse events including stent dysfunction as secondary objectives.
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
- •1.> 19years 2.malignant biliary obstruction, 2 cm distal to hilum 3.unsuitable for curative surgical resection owing to metastasis, locally advanced stage, high operation risk, or patient's refusal
排除标准
- •1.history of biliary surgery except cholecystectomy 2.history of SEMS placement 3.coagulopathy (INR>1.5, Platelet<50000) 4.expected survival > 3 months based on Karnofsky performance score 5.duodenal stricture
研究组 & 干预措施
partially covered SEMS
Deployment of Partially covered biliary self expandable metal stent
干预措施: partially covered SEMS (Device)
fully covered SEMS
Deployment of Fully covered biliary self expandable metal stent
干预措施: fully covered SEMS (Device)
结局指标
主要结局
duration of stent patency
时间窗: From the date of randomization until the date of first documented stent dysfunction, assessed upto 12 months
次要结局
- stent related complication(From the date of randomization until the date of first documented stent related complication, assessed up to 12 months)
- overall survival(From the date of randomization until the date of death from any cause, assessed upto 12 months)
- stent occlusion rate(From the date of randomization until the date of first documented stent occlusion, assessed up to 12 months)