Treatment of Biliary Obstruction Using Biliary Stent With or Without Antireflux Valve
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- patency of a biliary stent
研究概览
简要总结
Biliary obstruction can be relieved by biliary stent. Ascending infection of biliary passage (cholangitis) causes hospitalization and obstruction of stents. Reflux of intestinal fluids through a stent is thought to be one of the causes of cholangitis. Stents with antireflux valves are designed to reduce the reflux from the bowel. The purpose of the study is to investigate prospectively whether it is possible to reduce the amount of infection and thus obstruction of biliary stent by using a stent with an antireflux valve compared to a normal stent without an antireflux valve.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-89
- •biliary obstruction in the lower two thirds of the choledochus
排除标准
- •allergy to contrast media
- •future pancreaticoduodenectomy
- •refusal from the study
- •previous stent
研究组 & 干预措施
biliary stent without an antireflux valve
patients with biliary obstruction who need a biliary stent, selected for the stent without an antireflux valve arm
干预措施: Cook´s biliary stent with an antireflux stent, normal biliary stent (Device)
biliary stent with an antireflux valve
patients with biliary obstruction, who need a biliary stent, selected for the stent with an antireflux valve arm
干预措施: Cook´s biliary stent with an antireflux stent, normal biliary stent (Device)
结局指标
主要结局
patency of a biliary stent
时间窗: one year
次要结局
- Cholangitis(one year)
研究者
Hanna Vihervaara
Ph.D.
Turku University Hospital