Kasai Portoenterostomy Timing and Outcomes in Biliary Atresia

NCT ID: NCT07328204

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2025-12-01

Brief Summary

What is this study about? This study aims to find out the best timing for a major surgery called Kasai portoenterostomy (Kasai surgery) in infants with a liver disease called biliary atresia. The investigators want to see if having the surgery earlier leads to better long-term health for the baby's own liver.

Why is this important? Doctors know that early surgery is important, but it's unclear exactly how early is best. Some babies have surgery within the first month, others within 2-3 months. The investigators want to carefully compare different time windows to see which one gives the child the best chance to keep their own liver healthy and avoid a liver transplant.

How will the study work?

This is an observational study. The investigators will not change the treatment any child receives. The investigators will enroll about 200 infants from 4-5 children's hospitals in China. The investigators will simply group the infants based on their actual age at surgery:

Group 1: Surgery at 28 days old or younger.

Group 2: Surgery between 29 and 60 days old.

Group 3: Surgery between 61 and 90 days old.

Group 4: Surgery between 91 and 120 days old.

The investigators will then follow all children for 2 years after their surgery.

What will the investigators measure? The main thing the investigators want to see is how many children in each group are alive with their own liver working well 2 years after surgery (without needing a transplant). The investigators will also check many other health factors, like liver function tests, nutrition, growth, complications (like infections), and the costs of care.

What is the goal? The results of this study will help doctors and families make better, evidence-based decisions about the best time to perform this critical surgery for babies with biliary atresia.

Conditions

Biliary Atresia

Study Design

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

Study Groups

≤28 days

This observational cohort consists of infants diagnosed with type III biliary atresia who receive Kasai portoenterostomy within the first 28 days of life. Group assignment is based solely on the actual age at surgery.

Kasai portoenterostomy

Intervention Type: PROCEDURE

All participants in this observational study receive the standard-of-care surgical procedure, Kasai portoenterostomy (KPE). There is no study-specific intervention. The sole factor that distinguishes the four study cohorts is the natural timing of this standard surgery in the clinical course, which serves as the exposure variable for comparison. The cohorts are defined as follows:

Cohort 1: KPE performed at or before 28 days of age.

Cohort 2: KPE performed between 29 and 60 days of age.

Cohort 3: KPE performed between 61 and 90 days of age.

Cohort 4: KPE performed between 91 and 120 days of age. Participants are grouped based on their actual age at surgery in real-world practice. The study aims to compare long-term outcomes across these pre-defined surgical timing strata.

29-60 days

This observational cohort consists of infants diagnosed with type III biliary atresia who receive Kasai portoenterostomy between 29 and 60 days of life. This is a naturalistic grouping based on real-world surgical timing.

Kasai portoenterostomy

Intervention Type: PROCEDURE

All participants in this observational study receive the standard-of-care surgical procedure, Kasai portoenterostomy (KPE). There is no study-specific intervention. The sole factor that distinguishes the four study cohorts is the natural timing of this standard surgery in the clinical course, which serves as the exposure variable for comparison. The cohorts are defined as follows:

Cohort 1: KPE performed at or before 28 days of age.

Cohort 2: KPE performed between 29 and 60 days of age.

Cohort 3: KPE performed between 61 and 90 days of age.

Cohort 4: KPE performed between 91 and 120 days of age. Participants are grouped based on their actual age at surgery in real-world practice. The study aims to compare long-term outcomes across these pre-defined surgical timing strata.

61-90 days

This observational cohort consists of infants diagnosed with type III biliary atresia who receive Kasai portoenterostomy between 61 and 90 days of life. The cohort is defined by the exposure variable (surgical age) for comparative analysis.

Kasai portoenterostomy

Intervention Type: PROCEDURE

All participants in this observational study receive the standard-of-care surgical procedure, Kasai portoenterostomy (KPE). There is no study-specific intervention. The sole factor that distinguishes the four study cohorts is the natural timing of this standard surgery in the clinical course, which serves as the exposure variable for comparison. The cohorts are defined as follows:

Cohort 1: KPE performed at or before 28 days of age.

Cohort 2: KPE performed between 29 and 60 days of age.

Cohort 3: KPE performed between 61 and 90 days of age.

Cohort 4: KPE performed between 91 and 120 days of age. Participants are grouped based on their actual age at surgery in real-world practice. The study aims to compare long-term outcomes across these pre-defined surgical timing strata.

91-120 days

This observational cohort consists of infants diagnosed with type III biliary atresia who receive Kasai portoenterostomy between 91 and 120 days of life. This group represents the latest surgical timing within the study protocol.

Kasai portoenterostomy

Intervention Type: PROCEDURE

All participants in this observational study receive the standard-of-care surgical procedure, Kasai portoenterostomy (KPE). There is no study-specific intervention. The sole factor that distinguishes the four study cohorts is the natural timing of this standard surgery in the clinical course, which serves as the exposure variable for comparison. The cohorts are defined as follows:

Cohort 1: KPE performed at or before 28 days of age.

Cohort 2: KPE performed between 29 and 60 days of age.

Cohort 3: KPE performed between 61 and 90 days of age.

Cohort 4: KPE performed between 91 and 120 days of age. Participants are grouped based on their actual age at surgery in real-world practice. The study aims to compare long-term outcomes across these pre-defined surgical timing strata.

Interventions

Kasai portoenterostomy

All participants in this observational study receive the standard-of-care surgical procedure, Kasai portoenterostomy (KPE). There is no study-specific intervention. The sole factor that distinguishes the four study cohorts is the natural timing of this standard surgery in the clinical course, which serves as the exposure variable for comparison. The cohorts are defined as follows:

Cohort 1: KPE performed at or before 28 days of age.

Cohort 2: KPE performed between 29 and 60 days of age.

Cohort 3: KPE performed between 61 and 90 days of age.

Cohort 4: KPE performed between 91 and 120 days of age. Participants are grouped based on their actual age at surgery in real-world practice. The study aims to compare long-term outcomes across these pre-defined surgical timing strata.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Infant age ≤ 120 days at the time of planned surgery.
• Diagnosis of type III biliary atresia confirmed by clinical presentation, laboratory tests (e.g., conjugated hyperbilirubinemia), and imaging studies (e.g., ultrasonography showing absent or abnormal gallbladder, triangular cord sign).
• Scheduled to undergo primary (first-time) Kasai portoenterostomy.
• Legal guardian(s) able to understand and provide written informed consent.

Exclusion Criteria

• Presence of other severe congenital malformations that significantly impact prognosis or surgical risk (e.g., complex congenital heart disease requiring intervention, syndromic biliary atresia as part of a polymalformation complex).
• Pre-existing evidence of decompensated cirrhosis (e.g., refractory ascites, hepatopulmonary syndrome, or hepatic encephalopathy) prior to surgery.
• Previous history of any liver surgery (including prior Kasai portoenterostomy attempt or liver biopsy via laparotomy).
• Any condition that, in the opinion of the investigator, would make the infant unsuitable for participation or could interfere with the completion of follow-up (e.g., severe concurrent infection, life-limiting non-hepatic disease).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Children's Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Yijiang Han/Han Yijiang

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, , China

Countries

China

Other Identifiers

CHZJU2025IIT013

Identifier Type: -

Identifier Source: org_study_id