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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Complications rate | The occurrences of long-term postoperative complications include recurrent cholangitis, pancreatitis, bile duct stones, liver failure, and other such conditions. | Through study completion, an average of 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Malignant transformation rate | The occurrence of malignant transformation associated with bile duct dilatation. | Through study completion, an average of 5 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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All patients with a definitive diagnosis of biliary dilation in the participating centers will be included.
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| Name | Affiliation | Role |
|---|---|---|
| Shuo Jin, PhD | Beijing Tsinghua Chang Gung Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tsinghua Chang Gung Hospital | Beijing | Beijing Municipality | 102218 | China |
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| ID | Term |
|---|---|
| D015529 | Choledochal Cyst |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
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| 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. | Through study completion, an average of 5 year |
| D004066 |
| Digestive System Diseases |
| D004065 | Digestive System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |