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

Recruiting

• Conditions: Biliary Atresia

• Registration Number: NCT05909033
• Lead Sponsor: Weibing Tang

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2017-05-20
• Status Verified: 2023-06
• Study First Submitted: 2023-06-08
• Study First Submitted QC: 2023-06-09
• Last Update Submitted: 2023-06-09
• Study First Posted: 2023-06-18
• Last Update Posted: 2023-06-18
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
NLS rate	through study completion, an average of 3 years	native liver survival rate

Secondary Outcome Measures

Name	Time	Method
age at KP	through study completion, an average of 3 years	age at kasai procedure
PC	through study completion, an average of 3 years	post cholangitis
JC	through study completion, an average of 3 years	jaudiance clearance

Trial Locations

Locations (1)

Children's Hospital of Nanjing Medical University; 🇨🇳 Nanjing, China