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

W

Weibing Tang

Status

Enrolling

Conditions

Biliary Atresia

Treatments

Procedure: Kasai procedure

Study type

Observational

Funder types

Other

Identifiers

NCT05909033
NanjingCH20230601

Details and patient eligibility

About

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.

Full description

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.

Enrollment

150 estimated patients

Sex

All

Ages

6 months to 6 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial contacts and locations

1

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Central trial contact

Changgui Lu, Dr

Data sourced from clinicaltrials.gov

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