Clinical Features and Prognosis of Asymptomatic Biliary Dilatation

NCT ID: NCT07028164

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1008 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-10-15

Brief 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. 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:

1. Database Establishment and Maintenance: Construct and continuously update a multicenter clinical database for asymptomatic BD patients in China, ensuring data completeness and accessibility.

2. 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.

3. 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Patients who have been definitive diagnosed with biliary dilation.

2. Patients aged between 0 and 80 years old, regardless of gender.

3. 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.

Exclusion Criteria

-

• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tsinghua Chang Gung Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shuo Jin

Associate Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shuo Jin, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tsinghua Chang Gung Hospital

Locations

Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

24640-0-01-1

Identifier Type: -

Identifier Source: org_study_id