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NCT Number: NCT07328204

Kasai Portoenterostomy Timing and Outcomes in Biliary Atresia

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.

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Key information

Conditions

Biliary Atresia Bile Duct Diseases Biliary Tract Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Kasai portoenterostomy

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.

Primary outcomes

  1. Native Liver Survival Rate

    Time frame: 24 months after Kasai surgery

    Percentage of participants alive without liver transplantation at 24 months post-operation.

Secondary outcomes

  1. Clearance of Jaundice

    Time frame: At 3 months and 6 months after surgery

    Proportion of participants achieving serum total bilirubin <20 μmol/L.

  2. Incidence of Postoperative Cholangitis

    Time frame: Within 24 months after surgery

    Proportion of participants experiencing ≥1 episode of cholangitis.

  3. Incidence of Portal Hypertension

    Time frame: Within 24 months after surgery

    Proportion diagnosed with portal hypertension.

  4. Longitudinal Change in Liver Enzymes

    Time frame: Preop, 2 weeks, 1, 3, 6, 12, 18, 24 months postop

    Trajectory of liver enzyme levels.

  5. Change in Weight-for-Age Z-score (WAZ)

    Time frame: Preop, 6, 12, 24 months postop

    Change in weight-for-age Z-score.

  6. Perioperative Complication Rate

    Time frame: Within 30 days after surgery

    Proportion with any complication.

Other outcomes

  1. Direct Medical Costs of BA Management

    Time frame: From surgery hospitalization until 24 months postop

    Total direct medical costs.

  2. Longitudinal Change in Serum 25-Hydroxyvitamin D Level

    Time frame: Preop, 6, 12, 24 months postop

    Change in 25(OH)D concentration.

  3. BA-Related Re-hospitalization Rate

    Time frame: Within 24 months after surgery

    Proportion re-hospitalized.

  4. Postoperative Hospital Length of Stay

    Time frame: From surgery to first discharge, assessed up to 60 days

    Postoperative Hospital Length of Stay

  5. Duration of Kasai Portoenterostomy

    Time frame: On the day of surgery

    Total operative time.

Sponsors and collaborators

Lead sponsor

The Children's Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study title

Comprehensive Efficacy Study of Kasai Portoenterostomy for Biliary Atresia Stratified by Refined Surgical Timing: A Prospective Multicenter Cohort Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 9, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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