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

Biliary Atresia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05909033
• Other study ID #: NanjingCH20230601
• Status: Recruiting
• Start date: May 20, 2017
• Est. completion date: July 1, 2023

Study information

• Verified date: June 2023
• Source: Nanjing Children's Hospital
• Contact: Changgui Lu, Dr
• Phone: 13770848448
• Email: luchanggui1984[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Biliary Atresia

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Children's Hospital of Nanjing Medical University	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
Weibing Tang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NLS rate	native liver survival rate	through study completion, an average of 3 years
Secondary	age at KP	age at kasai procedure	through study completion, an average of 3 years
Secondary	PC	post cholangitis	through study completion, an average of 3 years
Secondary	JC	jaudiance clearance	through study completion, an average of 3 years