NCT00493675撤回1 期
Biodegradable Biliary Stent for Post Operative Cystic Duct Leakage. Pilot Study
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
- 否
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
研究点 (2)
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