Clinical trial NCT05909033: Early Predictors for the Short Term Native Liver Survival in Patients With Biliary Atresia After Kasai Procedure
Official title: Early Predictors for the Short Term Native Liver Survival in Patients With Biliary Atresia After Kasai Procedure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Biliary Atresia
Keywords: biliary Atresia
Kasai procedure
early predictor
native liver survival
Lead sponsor: Nanjing Children's Hospital
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with Biliary atreisa and were performed with kasai procedures

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.

Eligibility criteria: 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

Primary outcomes:
measure: NLS rate
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
measure: age at KP
timeFrame: through study completion, an average of 3 years
measure: PC
timeFrame: through study completion, an average of 3 years
measure: JC
timeFrame: through study completion, an average of 3 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Children's Hospital of Nanjing Medical University
Study officials:
affiliation: Children's Hospital of Nanjing Medical University
name: Weibing Tang, Dr
role: STUDY_DIRECTOR
affiliation: Children's Hospital of Nanjing Medical University
name: Weibing Tang, Dr
role: PRINCIPAL_INVESTIGATOR
References: