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Timing is everything: new study seeks optimal age for Life-Saving baby liver surgery

NCT ID NCT07328204

Knowledge-focused Sponsor: The Children's Hospital of Zhejiang University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study followed 200 babies with biliary atresia who had Kasai surgery at different ages to see which timing gives the best chance of keeping their own liver healthy for two years. Researchers grouped babies by surgery age (from under 28 days to 120 days) and tracked how many avoided a liver transplant. The goal is to give doctors clearer guidance on when to perform this critical surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors choose the best time for Kasai surgery, potentially improving the chance that babies with biliary atresia keep their own liver without needing a transplant.
What could go wrong
This is an observational study, not a controlled trial, so it can show links but not prove cause and effect. Results may not apply to all populations or hospitals.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

200 people

The number who actually took part.

Started

Dec 2025

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This prospective observational cohort study will enroll approximately 200 infants (age ≤120 days) diagnosed with type III biliary atresia (BA) who are scheduled to undergo their first (primary) Kasai portoenterostomy (KPE). Participants will be recruited from 4-5 pediatric tertiary care centers in China. Enrollment is based on real-world clinical presentation and surgical planning; no study-specific intervention is administered. Infants will be grouped into four natural cohorts according to their actual age at surgery: ≤28 days, 29-60 days, 61-90 days, and 91-120 days. The population will be followed prospectively for 24 months postoperatively to compare long-term outcomes across these surgical timing strata.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

biliary atresia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Biliary atresia

Contacts and locations

Locations

  • Children's Hospital, Zhejiang University School of Medicine

    Hangzhou, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.