Choledochal CystNCT07028164
Clinical Features and Prognosis of Asymptomatic Biliary Dilatation
An observational study of Choledochal Cyst, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
This study is a multicenter, ambidirectional cohort study aiming to consecutively recruit asymptomatic biliary dilation patients incidentally discovered by imaging from 25 medical centers across China. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Choledochal Cyst
- How many people
- 1,008 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 15 Oct 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with a definitive diagnosis of biliary dilation in the participating centers will be included.
Who may be able to join
- Patients who have been definitive diagnosed with biliary dilation.
- Patients aged between 0 and 80 years old, regardless of gender.
- In line with the principle of informed consent: For the retrospective cohort of biliary dilation, exemption from signing the informed consent form is applied for, while for the prospective cohort, signing the informed consent form is required.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tsinghua Chang Gung Hospital
Beijing, Beijing Municipality, 102218
About this study
Official title: Epidemiology, Prognosis, and Treatment Effectiveness of Asymptomatic Biliary Dilatation
This study is a multicenter, ambidirectional cohort study aiming to consecutively recruit asymptomatic biliary dilation patients incidentally discovered by imaging from 25 medical centers across China. The investigators will collect comprehensive clinicopathological data from the cohort to evaluate the epidemiological characteristics of asymptomatic patients, the distribution of Todani classifications, common imaging-detected comorbidities, and natural history; and, based on high-quality evidence, assess whether surgical intervention can improve the prognosis of asymptomatic patients, thereby providing a basis for developing targeted surveillance and intervention strategies.
Read the detailed description
Biliary dilation (BD) is a common and complex benign biliary disorder, for which surgical resection remains the only definitive treatment. However, while there are numerous studies on symptomatic BD, there is a lack of systematic, reliable data that describing the population structure, complication rates, comparing natural history and postoperative outcomes of patients whom incidentally detected by imaging and have no biliary symptoms. This multicenter, ambidirectional cohort study aims to consecutively recruit asymptomatic BD patients from 25 tertiary medical centers across China and to systematically collect their clinicopathological data-including demographic characteristics, baseline clinical features, laboratory and imaging results, biliary specific biomarkers, and longitudinal follow up records-in order to establish an asymptomatic subcohort within the larger China BD cohort. Based on this subcohort, the research objectives are structured as follows:
- Database Establishment and Maintenance: Construct and continuously update a multicenter clinical database for asymptomatic BD patients in China, ensuring data completeness and accessibility.
- Epidemiological Characterization of Asymptomatic BD: Describe the epidemiological features of asymptomatic BD patients, including demographic profiles (age, sex), distribution of Todani classifications, incidence of various complications, and risk of malignant transformation.
- Comparison of Surgical Treatment Versus Conservative Observation: Compare key clinical outcomes between asymptomatic BD patients who undergo surgical intervention and those managed by medical observation, thereby providing evidence-based guidance for clinical decision making in this population.
- Conditions
- Choledochal Cyst
- Keywords
- Cohort study, Clinical database, Surgical treatment, Long-term outcome, Asymptomatic Biliary Dilatation, Natural outcome
- 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 |
|---|---|---|
| Retrospective cohort | This cohort retrospectively collects all available clinical data and prognostic information of all patients who were previously diagnosed with asymptomatic biliary dilatation in the participating centers, and compares the various outcome indicators of two groups or multiple groups. | |
| Prospective cohort | This cohort prospectively enrolls all patients with a clear diagnosis of biliary dilatation in each participating center, tracks and observes them for a certain period of time, and compares the various outcome indicators of two groups or multiple groups. Additionally, it conducts prospective follow-ups on the patients in the retrospective cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications rate
The occurrences of long-term postoperative complications include recurrent cholangitis, pancreatitis, bile duct stones, liver failure, and other such conditions.
Measured: Through study completion, an average of 5 years
Secondary outcomes (1)
Malignant transformation rate
The occurrence of malignant transformation associated with bile duct dilatation.
Measured: Through study completion, an average of 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start1 Jan 2024
- Primary completion30 Jul 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choledochal CystStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 1,008 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuo Jin, Beijing Tsinghua Chang Gung Hospital
- Investigators
- Shuo Jin, PhD, Principal investigator, Beijing Tsinghua Chang Gung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028164
- Sponsor's protocol ID
- 24640-0-01-1
- Status last verified
- Nov 2025
- First submitted
- 2 Jun 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology, Prognosis, and Treatment Effectiveness of Asymptomatic Biliary Dilatation
- ClinicalTrials.gov ID
- NCT07028164
- Acronym / sponsor ID
- 24640-0-01-1
- Conditions
- Choledochal Cyst
- Keywords
- Cohort study, Clinical database, Surgical treatment, Long-term outcome, Asymptomatic Biliary Dilatation, Natural outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,008 participants (actual)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 19 Jun 2025 (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.
This study is a multicenter, ambidirectional cohort study aiming to consecutively recruit asymptomatic biliary dilation patients incidentally discovered by imaging from 25 medical centers across China. The investigators will collect comprehensive clinicopathological data from the cohort to evaluate the epidemiological characteristics of asymptomatic patients, the distribution of Todani classifications, common imaging-detected comorbidities, and natural history; and, based on high-quality evidence, assess whether surgical intervention can improve the prognosis of asymptomatic patients, thereby providing a basis for developing targeted surveillance and intervention strategies.
Detailed description
Biliary dilation (BD) is a common and complex benign biliary disorder, for which surgical resection remains the only definitive treatment. However, while there are numerous studies on symptomatic BD, there is a lack of systematic, reliable data that describing the population structure, complication rates, comparing natural history and postoperative outcomes of patients whom incidentally detected by imaging and have no biliary symptoms. This multicenter, ambidirectional cohort study aims to consecutively recruit asymptomatic BD patients from 25 tertiary medical centers across China and to systematically collect their clinicopathological data-including demographic characteristics, baseline clinical features, laboratory and imaging results, biliary specific biomarkers, and longitudinal follow up records-in order to establish an asymptomatic subcohort within the larger China BD cohort. Based on this subcohort, the research objectives are structured as follows:
- Database Establishment and Maintenance: Construct and continuously update a multicenter clinical database for asymptomatic BD patients in China, ensuring data completeness and accessibility.
- Epidemiological Characterization of Asymptomatic BD: Describe the epidemiological features of asymptomatic BD patients, including demographic profiles (age, sex), distribution of Todani classifications, incidence of various complications, and risk of malignant transformation.
- Comparison of Surgical Treatment Versus Conservative Observation: Compare key clinical outcomes between asymptomatic BD patients who undergo surgical intervention and those managed by medical observation, thereby providing evidence-based guidance for clinical decision making in this population.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | –This cohort retrospectively collects all available clinical data and prognostic information of all patients who were previously diagnosed with asymptomatic biliary dilatation in the participating centers, and compares the various outcome indicators of two groups or multiple groups. |
| Prospective cohort | – | –This cohort prospectively enrolls all patients with a clear diagnosis of biliary dilatation in each participating center, tracks and observes them for a certain period of time, and compares the various outcome indicators of two groups or multiple groups. Additionally, it conducts prospective follow-ups on the patients in the retrospective cohort. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with a definitive diagnosis of biliary dilation in the participating centers will be included.
Key inclusion criteria (3 listed)
- Patients who have been definitive diagnosed with biliary dilation.
- Patients aged between 0 and 80 years old, regardless of gender.
- In line with the principle of informed consent: For the retrospective cohort of biliary dilation, exemption from signing the informed consent form is applied for, while for the prospective cohort, signing the informed consent form is required.
Key exclusion criteria (1 listed)
- -
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
Complications rate
Time frame: Through study completion, an average of 5 years
The occurrences of long-term postoperative complications include recurrent cholangitis, pancreatitis, bile duct stones, liver failure, and other such conditions.
1 secondary outcome
Malignant transformation rate
Time frame: Through study completion, an average of 5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- 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. This study is not recruiting at the moment.
Shuo Jin, PhD principal investigator
Beijing Tsinghua Chang Gung Hospital
1 site 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 Beijing Tsinghua Chang Gung Hospital at 1 site 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 3 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: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications rate (time frame: Through study completion, an average of 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2025.