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临床试验/NCT00990366
NCT00990366终止不适用

Treatment of Biliary Obstruction Using Biliary Stent With or Without Antireflux Valve

Turku University Hospital2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
15
试验地点
2
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

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

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

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Hanna Vihervaara

Ph.D.

Turku University Hospital

研究点 (2)

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