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临床试验/NCT05909033
NCT05909033招募中不适用

Early Predictors for the Short Term Native Liver Survival in Patients With Biliary Atresia After Kasai Procedure

Weibing Tang1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
Weibing Tang
入组人数
150
试验地点
1
主要终点
NLS rate

研究概览

简要总结

Many factors have been proven that may affect NLS in BA patients after KP;however,the early predictors for NLS were not be finally detected.This study was designed to evaluate and identify the preoperative and early postoperative factors associated with NLS for early prediction in BA patients after KP.

详细描述

Biliary atresia (BA) is the most common cause of neonatal cholestasis, occurring in approximately 1: 8000 to 1:15000 in Asian populations compared with those in Europe and the USA, with a ratio of 1: 1.56 in males and females.Until now, Kasai procedure(KP) remains the preferred treatment for biliary BA;however,nearly 60-70% patients after KP need liver transplants to achieve long-term survival.Therefore, it is meaningful to seek and analyze the factors affecting the native liver survival(NLS) in BA patients with KP for prediction. Luckily, A lot of studies have designed to seek the risk factors for death or liver transplants in BA patients after KP,and many factors have been proven that may affect NLS,including old age at KP,low gamma-glutamyl transpeptidase(GGT) level,Cytomegalovirus(CMV) Infection,early jaundice clearance(JC) and postoperative cholangitis(PC),etal.However,the predictors for NLS were not be finally detected.Otherwise,the safety of liver transplants has been improved in the past few years and performing liver transplant in young infants has been proven to be feasible.Then,it is important to seek early NLS predictors for counseling the necessity and timing of liver transplant.Unfortunately,early predictors of NLS focus on preoperative and early postoperative period after KP were insufficient.

This study is primarily designed to evaluate and identify the preoperative and early postoperative factors associated with NLS for early prediction in BA patients after KP.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
6 Months 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Biliary Atresia(BA) patients performed with Kasai Procedure patients completed the follow-up>6 months

排除标准

  • BA patients without KP patients lost of follow-up BA patients with other severe complications lead to death

结局指标

主要结局

NLS rate

时间窗: through study completion, an average of 3 years

native liver survival rate

次要结局

  • age at KP(through study completion, an average of 3 years)
  • PC(through study completion, an average of 3 years)
  • JC(through study completion, an average of 3 years)

研究者

发起方
Weibing Tang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Weibing Tang

Clinical Professor

Nanjing Children's Hospital

研究点 (1)

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