A Longitudinal Cohort Study on the Changes of Physiological Mechanisms in Children After Biliary Tract Reconstruction

April 7, 2026 updated by: Xueqiang Yan, Wuhan Children's Hospital
Through observational studies, the long-term changes in liver function, metabolic state, immune response and other aspects of children after biliary tract reconstruction during their growth process were systematically explored. The risks of these long-term physiological changes on chronic diseases such as cardiovascular diseases, diabetic diseases and liver cirrhosis in adulthood, as well as their impacts on cognitive function, musculoskeletal health and other aspects were evaluated. How do early physiological changes affect a patient's long-term health? Are there any potential biomarkers that can predict future health outcomes? Based on the research results, preventive and intervention measures that are helpful in reducing the risk of long-term complications are proposed.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Children who were diagnosed with biliary atresia or choledochal cyst after birth and underwent biliary reconstruction surgery were selected. According to the year Stratified by factors such as age, gender and operation time to ensure the representativeness of the samples.

Description

Inclusion Criteria:

  • Healthy children matched by age and gender were selected as the control group

Exclusion Criteria:

  • Combined with other serious diseases (such as cancer, autoimmune diseases), having obvious liver function abnormalities before surgery or being undergoing other major treatments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Children diagnosed with biliary atresia or choledochal cyst and undergoing biliary reconstruction
Healthy children matched by age and gender were selected as the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Targeted metabolic component detection of feces
Time Frame: Baseline (pre-operative); 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years post-operative
Metabolite concentration in feces measured by targeted metabolomics
Baseline (pre-operative); 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years post-operative
Detection of targeted metabolic components in plasma
Time Frame: Baseline (pre-operative); 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years post-operative
Metabolite concentration in plasma measured by targeted metabolomics
Baseline (pre-operative); 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fecal metagenomic sequencing
Time Frame: Baseline (pre-operative); 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years post-operative
Gut microbial composition and functional genes assessed by fecal metagenomic sequencing
Baseline (pre-operative); 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

April 1, 2035

Study Completion (Estimated)

April 30, 2035

Study Registration Dates

First Submitted

June 22, 2025

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Wuhan Children's Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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