跳至主要内容
临床试验/NCT01232101
NCT01232101已完成不适用

Covered and Uncovered Self Expandable Metallic Stents Are Equally Efficacious in Bile Duct Strictures. Results of a Randomized Study.

Göteborg University2 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2007年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
71
试验地点
2
主要终点
The primary aim of the present study was to compare and stent patency between covered and uncovered bileduct SEMS

研究概览

简要总结

The study is investigator initiated. Tumors that gives the narrowing of the bile ducts prevents bile from flowing from the liver to the intestine resulting in jaundice and the risk of bacterial growth in bile with severe infections as a result. Unresectable bile duct strictures have routinely been treated them with plastic stents. The plastic stents have been replaced by self expandable metallic stents.

These stents remain open longer for reasons that they have a larger diameter so that the bile flows through more easily. One problem with these stents, however, is that the tumor growing through the wire mesh which forms the wall of the stent. This has led to the development of so-called covered stents. Whether covered stents have longer patency is unclear as well as whether they are as safe. There is reason to believe that covered stents remain open longer, but there may be an increased risk of migration and other complications.

The purpose is to prospectively and randomized compare the two stent types. The study endpoint is the clogging of the stent or the patient's death. We also monitor complications, regress time of the jaundice and success rate of stent placement

详细描述

0

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with unresectable, distal bile duct stricture needing relieved endoscopically
  • Expected survival greater than 3 months
  • The patient must give written consent to participate in the study

排除标准

  • Stricture close to hilus
  • Need for interpreter

结局指标

主要结局

The primary aim of the present study was to compare and stent patency between covered and uncovered bileduct SEMS

时间窗: Stent occlusion or patient death

次要结局

  • Secondary objectives were to study difference in technical success, efficacy of drainage and complication rate between covered and uncovered metal stents(Evaluated within three days)

研究者

发起方
Göteborg University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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