Actively Recruiting

Age: 0 - 16Years
All Genders
Healthy Volunteers
ID07530354

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

Led by Wuhan Children's Hospital · Updated on 2026-04-15

100

Participants Needed

3

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a long-term observational study to understand how physiological changes in children after biliary tract reconstruction affect their health over time. The study focuses on changes in liver function, metabolism, immune response, and other bodily functions as children grow. It also evaluates the risks these changes might pose for chronic illnesses like cardiovascular disease, diabetes, and liver cirrhosis in adulthood, as well as their effects on cognitive and musculoskeletal health. The goal is to identify early biomarkers that predict future health outcomes and to suggest preventive or intervention strategies to reduce long-term complications. The study follows children diagnosed with biliary atresia or choledochal cyst who have undergone biliary reconstruction surgery. A control group of healthy children matched by age and gender will also be observed for comparison. Researchers will collect samples and data at multiple time points: before surgery, then at 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years after surgery. These data include targeted metabolic components detected in feces and plasma, along with fecal metagenomic sequencing. Participants will be monitored over several years through scheduled assessments to track metabolic and microbiome changes. The study will measure specific metabolic components in fecal and blood samples at each time point to observe ongoing physiological changes. By following both surgical patients and healthy controls, researchers aim to understand the long-term impacts of biliary reconstruction on children's health and identify ways to reduce future health risks. The study enrollment starts in May 2025 and continues until April 2035.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 16Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy children matched by age and gender were selected as the control group
Not Eligible

You will not qualify if you...

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 1 week

Participants undergo biliary tract reconstruction surgery followed by immediate post-operative care.

1 surgical visit and several in-hospital post-operative assessments

Post-operative Follow-up

Duration - 3 years

Participants are monitored through repeated assessments of metabolic components and fecal metagenomic sequencing to observe physiological changes over time.

Visits at 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, and 3 years post-operative

Trial Site Locations

Total: 3 locations

1

Wuhan Children's Hospital

Wuhan, Hubei, China, 430016

Actively Recruiting

2

Wuhan Children'S Hospital

Wuhan, Hubei, China, 430016

Actively Recruiting

3

Wuhan Children'S Hospital

Wuhan, Hubei, China, 430016

Actively Recruiting

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Research Team

X

Xueqiang Yan

J

Jing Zhang

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

What is the incidence of biliary carcinoma in choledochal cysts, when do they develop, and how should it affect management?

Amit V Sastry, Benjamin Abbadessa, Michael G Wayne...

https://pubmed.ncbi.nlm.nih.gov/25322698

Clinical characteristics of patients with malignancy and long-term outcomes of surgical treatment of patients with choledochal cyst.

Wung Sun Han, Hongbeom Kim, Hee Ju Sohn...

https://pubmed.ncbi.nlm.nih.gov/34934760