Phase IIIb Study of Corticosteroids as Post-Operative Adjuvant Therapy in Biliary Atresia
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- clearance of jaundice (<20 umol/L)
研究概览
简要总结
Biliary atresia is a congenital disorder of bile duct development or destruction of established but immature bile ducts. The study tests the hypothesis that post-operative steroids improve outcome following the Kasai procedure - the commonest surgical treatment.
详细描述
Biliary atresia is a potentially fatal condition of infants presenting as persisting jaundice in the first few weeks of life. The disease is characterised by obstruction and damage to the intra and extrahepatic parts of the biliary tree. Within the liver there is also a pronounced inflammatory response. The initial treatment is an attempt, by surgery, to restore bile flow by excising the obliterated extrahepatic bile ducts and joining part of the intestine to the bile "root" of the liver (the porta hepatis). This is known as the Kasai procedure. This is successful in ~50% of cases in reducing the level of jaundice to near-normal values. The use of steroids post-operatively has been suggested as improving outcome by diminishing the inflammatory response.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 100 Days(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •biliary atresia
排除标准
- •<100 days at portoenterostomy
- •no other anomalies (e.g. Biliary Atresia Splenic Malformation syndrome)
- •anu contra-indications to corticosteroids
研究组 & 干预措施
A
oral corticosteroids
干预措施: prednisolone (Drug)
B
as for active regimen
干预措施: placebo (Drug)
结局指标
主要结局
clearance of jaundice (<20 umol/L)
时间窗: 1 year
Proportion transplanted or died
时间窗: 1 year
次要结局
- biochemical indices of liver function(1 year)
