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

NCT ID: NCT05909033

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-20
• Study Completion Date: 2023-07-01

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.

Conditions

Biliary Atresia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Kasai procedure

All KPs were performed by a medical team. This technique involved creation of a 35-40 cm Roux loop to facilitate biliary drainage. After dissection of the hepatic vasculature at the hilum and excision of the hilar plate, hepaticojejunostomy was performed as an anastomosis extending from the bifurcation of the right hepatic artery into anterior and posterior branches to the Rex confluence of the left portal vein with the obliterated umbilical vein.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weibing Tang

OTHER

Sponsor Role: lead

Responsible Party

Weibing Tang

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Weibing Tang, Dr

Role: STUDY_DIRECTOR

Children's Hospital of Nanjing Medical University

Weibing Tang, Dr

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Nanjing Medical University

Locations

Children's Hospital of Nanjing Medical University

Nanjing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Changgui Lu, Dr

Role: CONTACT

luchanggui1984@163.com

13770848448

Facility Contacts

Changgui Lu, Dr

Role: primary

luchanggui1984@163.com

References

Lu C, Xie H, Zhu Z, Ding Z, Geng Q, Tang W. A convenient nomogram for predicting early death or liver transplantation after the Kasai procedure in patients with biliary atresia. Langenbecks Arch Surg. 2024 Jan 8;409(1):30. doi: 10.1007/s00423-023-03216-5.

Reference Type: DERIVED

PMID: 38189999 (View on PubMed)

Other Identifiers

NanjingCH20230601

Identifier Type: -

Identifier Source: org_study_id