A Longitudinal Cohort Study on the Changes of Physiological Mechanisms in Children After Biliary Tract Reconstruction
1 other identifier
observational
100
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2025
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2025
CompletedFirst Submitted
Initial submission to the registry
June 22, 2025
CompletedFirst Posted
Study publicly available on registry
April 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2035
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2035
April 15, 2026
April 1, 2026
9.9 years
June 22, 2025
April 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Targeted metabolic component detection of feces
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
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 Outcomes (1)
Fecal metagenomic sequencing
Baseline (pre-operative); 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years post-operative
Study Arms (2)
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
Eligibility Criteria
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.
You may qualify if:
- Healthy children matched by age and gender were selected as the control group
You may not qualify if:
- Combined with other serious diseases (such as cancer, autoimmune diseases), having obvious liver function abnormalities before surgery or being undergoing other major treatments.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Wuhan Children's Hospital
Wuhan, Hubei, 430016, China
Wuhan Children'S Hospital
Wuhan, Hubei, 430016, China
Wuhan Children'S Hospital
Wuhan, Hubei, 430016, China
Related Publications (6)
Sastry AV, Abbadessa B, Wayne MG, Steele JG, Cooperman AM. What is the incidence of biliary carcinoma in choledochal cysts, when do they develop, and how should it affect management? World J Surg. 2015 Feb;39(2):487-92. doi: 10.1007/s00268-014-2831-5.
PMID: 25322698BACKGROUNDHan WS, Kim H, Sohn HJ, Lee M, Kang YH, Kim HS, Han Y, Kang JS, Kwon W, Jang JY. Clinical characteristics of patients with malignancy and long-term outcomes of surgical treatment of patients with choledochal cyst. Ann Surg Treat Res. 2021 Dec;101(6):332-339. doi: 10.4174/astr.2021.101.6.332. Epub 2021 Dec 1.
PMID: 34934760BACKGROUNDKowalski A, Kowalewski G, Kalicinski P, Pankowska-Wozniak K, Szymczak M, Ismail H, Stefanowicz M. Choledochal Cyst Excision in Infants-A Retrospective Study. Children (Basel). 2023 Feb 14;10(2):373. doi: 10.3390/children10020373.
PMID: 36832502BACKGROUNDBabbitt DP. [Congenital choledochal cysts: new etiological concept based on anomalous relationships of the common bile duct and pancreatic bulb]. Ann Radiol (Paris). 1969;12(3):231-40. No abstract available. Multiple languages.
PMID: 5401505BACKGROUNDNguyen SH, Abella M, Gutierrez JV, Tabak B, Puapong D, Johnson S, Woo RK. Robotic Surgery for Pediatric Choledochal Cysts: An American Case Series and Literature Review. J Surg Res. 2023 Nov;291:473-479. doi: 10.1016/j.jss.2023.06.034. Epub 2023 Jul 31.
PMID: 37531675BACKGROUNDScharli A, Bettex M. Congenital choledochal cyst: reconstruction of the normal anatomy. J Pediatr Surg. 1968 Oct;3(5):604-7. doi: 10.1016/0022-3468(68)90113-9. No abstract available.
PMID: 5681670BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 22, 2025
First Posted
April 15, 2026
Study Start
May 1, 2025
Primary Completion (Estimated)
April 1, 2035
Study Completion (Estimated)
April 30, 2035
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share