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Recruiting NCT07530354

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

— Observational Choledochal Cyst

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Choledochal Cyst. Basic parameters: up to 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • 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]
  • 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]
Secondary outcome measures (1)
  • Fecal metagenomic sequencing [Time frame: Baseline (pre-operative); 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years post-operative]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 3 centers
  • Wuhan Children's Hospital — Wuhan
  • Wuhan Children'S Hospital — Wuhan
  • Wuhan Children'S Hospital — Wuhan

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 5681670

Identifiers

NCT: NCT07530354 · Wuhan Children's Hospital

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗