Prospective Trial on Survival With Own Liver After Conventional Versus Laparoscopic Kasai for Biliary Atresia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Survival with own liver at 6 months after the Kasai operation without beeing listed for liver transplantation
研究概览
简要总结
This study evaluated laparoscopic (videosurgery) versus conventional (open surgery) Kasai portoenterostomy (anastomosis of small intestine to the liver hilus) in children with biliary atresia. The study was stopped due to lower survival with native liver 6 months after the laparoscopic operation. Follow-up after 24 months confirmed superior results after conventional operation.
详细描述
Objective:
A prospective observational study to compare survival with own liver in laparoscopic versus conventional Kasai portoenterostomy in patients with biliary atresia.
Summary Background Data:
Available studies on laparoscopic versus conventional Kasai portoenterostomy focus on short-term results, include limited numbers of patients and have design limitations.
Methods:
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
- 1 Month 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biliary atresia
排除标准
- •< 3000 grs. body weight
- •Syndromatic form of biliary atresia
- •Significant comorbidity i.e. cardiac
- •Contraindication to laparoscopy
结局指标
主要结局
Survival with own liver at 6 months after the Kasai operation without beeing listed for liver transplantation
时间窗: one year
次要结局
- Jaundice free survival confirmed by serum bilirubin < 20 umol/l(6 months)
- Feasibility of laparoscopic Kasai with regard to conversions and revisions(3 months)