NCT01393067已完成不适用
Comparison of Use of Covered, Self-expandable Metal Stents (cSEMS) and Non-expandable Plastic Stents (NEPS) in Temporary Endoscopic Treatment of Stenosis of the Bilio-biliary Anastomosis After Liver Transplantation
Johann Wolfgang Goethe University Hospital7 个研究点 分布在 3 个国家目标入组 60 人开始时间: 2011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
- 60
- 试验地点
- 7
- 主要终点
- Number of interventions (ERCP) to attain resolution of stenosis
研究概览
简要总结
Stenosis at the bilio-biliary anastomosis occurs in up to 30% of patients after orthotopic liver transplantation. This study compares endoscopic treatment with implantation of multiple plastic endoprostheses vs. use of a removable, covered self-expandable metal stent (cSEMS).
详细描述
This is a multi-center randomised trial.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •post-OLT stenosis of the bilio-biliary anastomotic
排除标准
- •non-anastomotic stricture
- •stent implatation technically not feasible
结局指标
主要结局
Number of interventions (ERCP) to attain resolution of stenosis
时间窗: up to one year
Number of interventions (ERC) in study group cSEMS is compared to number of interventions (ERC) in study group NEPS
次要结局
- Occurence and severity of complications related to the endoscopic procedures(up to 2 months after ERCP)
研究者
Jorg Albert
Johann Wolfgang Goethe University Hospitals.
Johann Wolfgang Goethe University Hospital
研究点 (7)
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