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RecruitingNCT07530354Updated Apr 15, 2026

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

An observational study in Choledochal Cyst, sponsored by Wuhan Children's Hospital. Recruiting at 3 sites in China. Open to participants aged Up to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-15.

Sponsored by Wuhan Children's Hospital · Observational

From the registry’s dates

  • Started May 2025; still recruiting 1 year 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
Up to 16 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Choledochal Cyst

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Keywords

  • Choledochal Cyst
  • Cholecystectomy
  • Cohort Studies
  • Treatment Outcome
  • Surgical Procedures
03

In context

Choledochal Cyst

22 studies on the registry are indexed under Choledochal Cyst; 10 are open to participants now.

This study's planned enrollment of 100 is below the median of 400 across 14 observational studies indexed under Choledochal Cyst.

Browse Choledochal Cyst studies →

Lead sponsor

Wuhan Children's Hospital is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 16 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Combined with other serious diseases (such as cancer, diseases), having obvious liver function abnormalities before surgery or being undergoing other major treatments.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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
06

What researchers measure

Primary outcomes

  1. Targeted metabolic component detection of feces

    Metabolite concentration in feces measured by targeted metabolomics

    Time frame: Baseline (pre-operative); 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years post-operative

  2. Detection of targeted metabolic components in plasma

    Metabolite concentration in plasma measured by targeted metabolomics

    Time frame: 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

    Gut microbial composition and functional genes assessed by fecal metagenomic sequencing

    Time frame: Baseline (pre-operative); 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years post-operative

07

Study locations

3 of 3 sites recruiting
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References and documents

Publications

  • 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. PubMed 25322698 ↗
  • Han 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. PubMed 34934760 ↗
  • Kowalski 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. PubMed 36832502 ↗
  • Babbitt 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. PubMed 5401505 ↗
  • Nguyen 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. PubMed 37531675 ↗
  • Scharli 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. PubMed 5681670 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07530354
Lead sponsor
Wuhan Children's Hospital
Responsible party
Xueqiang Yan (Principal Investigator, Wuhan Children's Hospital) — Principal investigator
First posted
Apr 15, 2026
Start date
May 1, 2025
Primary completion
Apr 2035 (estimated)
Completion
Apr 30, 2035 (estimated)
Last update
Apr 15, 2026

Study contacts

Xueqiang Yan
Contact
yanxueqiang1@163.com
+8615871716704
Jing Zhang
Contact
zhanjing010308@163.com
+8613396086020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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