An observational study in Choledochal Cyst, sponsored by Beijing Tsinghua Chang Gung Hospital. Completed at 1 site in China. Open to participants aged Up to 80 Years. Per ClinicalTrials.gov, last updated 2025-11-26.
Sponsored by Beijing Tsinghua Chang Gung Hospital · Observational
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.
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:
22 studies on the registry are indexed under Choledochal Cyst; 10 are open to participants now.
This study's enrollment of 1,008 is above the median of 400 across 14 observational studies indexed under Choledochal Cyst.
Browse Choledochal Cyst studies →Beijing Tsinghua Chang Gung Hospital is the lead sponsor of 108 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients with a definitive diagnosis of biliary dilation in the participating centers will be included.
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.
Exclusion Criteria:
-
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Complications rate
The occurrences of long-term postoperative complications include recurrent cholangitis, pancreatitis, bile duct stones, liver failure, and other such conditions.
Time frame: Through study completion, an average of 5 years
Malignant transformation rate
The occurrence of malignant transformation associated with bile duct dilatation.
Time frame: Through study completion, an average of 5 year
Mayo Score
The scoring results are categorized into four levels: Excellent: Biochemical tests are normal, no clinical symptoms, no anatomical abnormalities; Good: No signs of cholangitis, only minor biliary structural abnormalities; biochemical indices are normal or near normal; no clinical intervention required; Fair: Mild structural biliary abnormalities; cholangitis episodes occur less than 3 times per year and respond to conservative management (e.g., antibiotics); Poor: Recurrent cholangitis (≥ 3 episodes per year); biliary anatomical anomalies (strictures and stones) not amenable to conservative management, requiring reoperation.
Time frame: Through study completion, an average of 5 year
the Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score
Patient-reported quality of life will be assessed using the PROMIS-29 Profile v2.1. This validated instrument consists of 29 items covering seven domains: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference (4 items per domain), as well as one item measuring pain intensity (0-10 numeric rating scale). Each domain score is converted to a standardized T-score (mean = 50, standard deviation = 10) based on general population. Higher scores indicate worse symptoms for anxiety, depression, fatigue, sleep disturbance, and pain interference. Higher scores indicate better status for physical function and social role participation.
Time frame: Through study completion, an average of 5 year
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2024 to primary completion in Jul 2025, 18 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Beijing Tsinghua Chang Gung Hospital →