Biliary AtresiaNCT07328204
Kasai Portoenterostomy Timing and Outcomes in Biliary Atresia
An observational study of Biliary Atresia, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Biliary Atresia
- What is being tested?
- Kasai portoenterostomy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital, Zhejiang University School of Medicine
Hangzhou
About this study
Official title: Comprehensive Efficacy Study of Kasai Portoenterostomy for Biliary Atresia Stratified by Refined Surgical Timing: A Prospective Multicenter Cohort Study
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.
Read more
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
- Being tested
- Kasai portoenterostomy
- Medical subject headings
- Biliary Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kasai portoenterostomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| ≤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. Receives: Procedure: Kasai portoenterostomy | |
| 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. Receives: Procedure: Kasai portoenterostomy | |
| 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. Receives: Procedure: Kasai portoenterostomy | |
| 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. Receives: Procedure: Kasai portoenterostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Native Liver Survival Rate
Percentage of participants alive without liver transplantation at 24 months post-operation.
Measured: 24 months after Kasai surgery
Secondary outcomes (6)
Clearance of Jaundice
Proportion of participants achieving serum total bilirubin <20 μmol/L.
Measured: At 3 months and 6 months after surgery
Incidence of Postoperative Cholangitis
Proportion of participants experiencing ≥1 episode of cholangitis.
Measured: Within 24 months after surgery
Incidence of Portal Hypertension
Proportion diagnosed with portal hypertension.
Measured: Within 24 months after surgery
Longitudinal Change in Liver Enzymes
Trajectory of liver enzyme levels.
Measured: Preop, 2 weeks, 1, 3, 6, 12, 18, 24 months postop
Change in Weight-for-Age Z-score (WAZ)
Change in weight-for-age Z-score.
Measured: Preop, 6, 12, 24 months postop
Perioperative Complication Rate
Proportion with any complication.
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Dec 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary AtresiaStudies of the same condition, open and under way.
- More trials run by The Children's Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yijiang Han/Han Yijiang, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328204
- Sponsor's protocol ID
- CHZJU2025IIT013
- Status last verified
- Jan 2026
- First submitted
- 26 Dec 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Efficacy Study of Kasai Portoenterostomy for Biliary Atresia Stratified by Refined Surgical Timing: A Prospective Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT07328204
- Acronym / sponsor ID
- CHZJU2025IIT013
- Conditions
- Biliary Atresia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ≤28 days | – | Procedure: Kasai portoenterostomyThis 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. |
| 29-60 days | – | Procedure: Kasai portoenterostomyThis 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. |
| 61-90 days | – | Procedure: Kasai portoenterostomyThis 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. |
| 91-120 days | – | Procedure: Kasai portoenterostomyThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kasai portoenterostomyAll 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. | Procedure or surgery | 29-60 days, 61-90 days, 91-120 days, ≤28 days |
Primary outcome
Native Liver Survival Rate
Time frame: 24 months after Kasai surgery
Percentage of participants alive without liver transplantation at 24 months post-operation.
6 secondary outcomes
Clearance of Jaundice
Time frame: At 3 months and 6 months after surgery
Incidence of Postoperative Cholangitis
Time frame: Within 24 months after surgery
Incidence of Portal Hypertension
Time frame: Within 24 months after surgery
Longitudinal Change in Liver Enzymes
Time frame: Preop, 2 weeks, 1, 3, 6, 12, 18, 24 months postop
Change in Weight-for-Age Z-score (WAZ)
Time frame: Preop, 6, 12, 24 months postop
Perioperative Complication Rate
Time frame: Within 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Atresia, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Native Liver Survival Rate (time frame: 24 months after Kasai surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.