Long-term physiological changes in children after biliary tract reconstruction
A Longitudinal Cohort Study on the Changes of Physiological Mechanisms in Children After Biliary Tract Reconstruction
Wuhan Children's Hospital · NCT07530354
This project will follow children who had biliary tract reconstruction for choledochal cyst to see if early changes in liver, metabolism, or immune function predict health problems later in life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | N/A to 16 Years |
| Sex | All |
| Sponsor | Wuhan Children's Hospital (other) |
| Locations | 3 sites (Wuhan, Hubei and 2 other locations) |
| Trial ID | NCT07530354 on ClinicalTrials.gov |
What this trial studies
This is a longitudinal observational cohort that follows children after biliary tract reconstruction and compares them with healthy age- and gender-matched controls. Researchers will monitor liver function, metabolic markers, immune responses, and other physiological measures over time and collect data on cognitive and musculoskeletal health. The study will look for biomarkers that link early postoperative changes to adult risks such as liver cirrhosis, diabetes, and cardiovascular disease. Results will be used to propose preventive or early-intervention measures to reduce long-term complications.
Who should consider this trial
Good fit: Children who have undergone biliary tract reconstruction for choledochal cyst, who do not have other major illnesses, and who can attend scheduled follow-up visits are ideal candidates.
Not a fit: Children with preexisting serious conditions (for example cancer or autoimmune disease), those with obvious liver dysfunction before surgery, or those unable to participate in long-term follow-up are unlikely to benefit from this observational project.
Why it matters
Potential benefit: If successful, the study could identify early warning signs and guide interventions that reduce the risk of liver disease, metabolic disorders, and other long-term complications in these patients.
How similar studies have performed: Smaller cohorts have tracked liver outcomes after biliary reconstruction, but comprehensive long-term work linking metabolic, immune, cognitive, and musculoskeletal outcomes is limited, so much of this approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Wuhan, Hubei and 2 other locations
- Wuhan Children's Hospital — Wuhan, Hubei, China (RECRUITING)
- Wuhan Children'S Hospital — Wuhan, Hubei, China (RECRUITING)
- Wuhan Children'S Hospital — Wuhan, Hubei, China (RECRUITING)
Study contacts
- Study coordinator: Xueqiang Yan
- Email: yanxueqiang1@163.com
- Phone: +8615871716704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Choledochal Cyst, Cholecystectomy, Cohort Studies, Treatment Outcome, Surgical Procedures