跳至主要内容
临床试验/NCT00493675
NCT00493675撤回1 期

Biodegradable Biliary Stent for Post Operative Cystic Duct Leakage. Pilot Study

Tampere University2 个研究点 分布在 1 个国家开始时间: 2006年6月最近更新:
适应症

试验速览

阶段
1 期
状态
撤回
试验地点
2
主要终点
Clinical healing of bile leakage

研究概览

简要总结

Endoscopic sphincterotomy and temporary stenting is a routine treatment for post cholecystectomy cystic duct leakage. The draw back is that the plastic stent need to be removed later in a second intervention. Our studies with animal models have demonstrated that biodegradable biliary stent is at least as good as conventional plastic stent to heal that kind of leakage. In this pilot study the biodegradable biliary stent is inserted endoscopically to patients with confirmed cystic duct leakage to demonstrate the efficacy in human setting.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with confirmed post cholecystectomy cystic duct leakage requiring endoscopic treatment

排除标准

  • 未提供

结局指标

主要结局

Clinical healing of bile leakage

时间窗: 1 month

次要结局

  • Laboratory tests for liver function, ultra sound for bile collections and bile duct diameter and abdominal plain X-ray for stent degradation(6 months)

研究者

申办方类型
Other

研究点 (2)

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