The Role of Transpapillary Stenting in the Treatment of Bile Leakage After Liver Transection.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of days of bile leakage from the abdominal cavity
研究概览
简要总结
Bile leakage after liver transection is treated by external drainage. The question addressed is whether downstream control by transpapillary stent insertion into distal bile duct can enhance healing.
详细描述
All patients who present with clinically significant bile leakage after liver resection at postoperative day two or longer are offered the opportunity to become randomized to either continuous external drainage or the addition of transpapillary stent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Liver resection including at least two liver segments.
排除标准
- •Hepatobiliary digestive anastomosis.
研究组 & 干预措施
Continued external drainage
Continued external drainage alone.
Continued external drainage + transpapillary stent
External drainage + transpapillary plastic stent (7-10 Fr).
干预措施: Transpapillary plastic stent (7-10 Fr) (Device)
结局指标
主要结局
Number of days of bile leakage from the abdominal cavity
时间窗: From intervention until day discharge from hospital
次要结局
- General complications rates. Postoperative hospital stay(From intervention until day of discharge from hospital)
研究者
Lars Lundell
Professor
Karolinska University Hospital