跳至主要内容
临床试验/NCT00539565
NCT00539565Unknown3 期

Phase IIIb Study of Corticosteroids as Post-Operative Adjuvant Therapy in Biliary Atresia

King's College Hospital NHS Trust1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2000年1月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

oral corticosteroids

干预措施: prednisolone (Drug)

B

Placebo Comparator

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)

研究者

发起方
King's College Hospital NHS Trust
申办方类型
Other

研究点 (1)

Loading locations...

相似试验