Choledochal CystNCT07530354
A Longitudinal Cohort Study on the Changes of Physiological Mechanisms in Children After Biliary Tract Reconstruction
An observational study of Choledochal Cyst, run by Wuhan Children's Hospital at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Choledochal Cyst
- How many people
- 100 participants
- Where
- 3 sitesChina
- Study dates
- 1 May 2025to 30 Apr 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Healthy children matched by age and gender were selected as the control group
Who cannot join
- Combined with other serious diseases (such as cancer, autoimmune diseases), having obvious liver function abnormalities before surgery or being undergoing other major treatments.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Wuhan Children's Hospital
Wuhan, Hubei, 430016
Xueqiang Yan, +8615871716704, yanxueqiang1@163.com
- Recruiting
Wuhan Children'S Hospital
Wuhan, Hubei, 430016
- Recruiting
Wuhan Children'S Hospital
Wuhan, Hubei, 430016
Xueqiang Yan, +8615871716704, yanxueqiang1@163.com
Jing Zhang, +8613396086020, zhanjing010308@163.com
About this study
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.
- Conditions
- Choledochal Cyst
- Keywords
- Choledochal Cyst, Cholecystectomy, Cohort Studies, Treatment Outcome, Surgical Procedures
- Medical subject headings
- Choledochal Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children diagnosed with biliary atresia or choledochal cyst and undergoing biliary reconstruction | Not described | |
| Healthy children matched by age and gender were selected as the control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Targeted metabolic component detection of feces
Metabolite concentration in feces measured by targeted metabolomics
Measured: 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
Measured: 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
Measured: Baseline (pre-operative); 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 May 2025
- Primary completionApr 2035 (estimated)
- Study completion30 Apr 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Choledochal CystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xueqiang Yan, Wuhan Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530354
- Sponsor's protocol ID
- Wuhan Children's Hospital
- Status last verified
- Apr 2026
- First submitted
- 22 Jun 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 25322698Han 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 34934760Kowalski 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 36832502Babbitt 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 5401505Nguyen 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 37531675Scharli 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Cohort Study on the Changes of Physiological Mechanisms in Children After Biliary Tract Reconstruction
- ClinicalTrials.gov ID
- NCT07530354
- Acronym / sponsor ID
- Wuhan Children's Hospital
- Conditions
- Choledochal Cyst
- Keywords
- Choledochal Cyst, Cholecystectomy, Cohort Studies, Treatment Outcome, Surgical Procedures
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wuhan Children's HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- Apr 2035 (estimated)
- Study completion
- 30 Apr 2035 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Healthy children matched by age and gender were selected as the control group
Key exclusion criteria (1 listed)
- Combined with other serious diseases (such as cancer, autoimmune diseases), having obvious liver function abnormalities before surgery or being undergoing other major treatments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Metabolite concentration in feces measured by targeted metabolomics
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
Metabolite concentration in plasma measured by targeted metabolomics
1 secondary outcome
Fecal metagenomic sequencing
Time frame: Baseline (pre-operative); 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Background: PubMed 25322698Sastry 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.
- Background: PubMed 34934760Han 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.
- Background: PubMed 36832502Kowalski 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.
- Background: PubMed 5401505Babbitt 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.
- Background: PubMed 37531675Nguyen 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.
- Background: PubMed 5681670Scharli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Choledochal Cyst, run by Wuhan Children's Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xueqiang Yan (+8615871716704, yanxueqiang1@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07530354, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.