Clinical Features and Prognosis of Asymptomatic Biliary Dilatation

NCT07028164 | Completed

• 1 other identifier: 24640-0-01-1
• Study Type: observational
• Target: 1,008
• Locations: 1 country
• Sites: 1

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.

Conditions

Choledochal Cyst

Keywords

Cohort study; Clinical database; Surgical treatment; Long-term outcome; Asymptomatic Biliary Dilatation; Natural outcome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Malignant transformation rate

  Through study completion, an average of 5 year

Other Outcomes (2)

• Mayo Score

  Through study completion, an average of 5 year

• the Patient-Reported Outcomes Measurement Information System (PROMIS-29) Score

  Through study completion, an average of 5 year

Study Arms (2)

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.

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with a definitive diagnosis of biliary dilation in the participating centers will be included.

You may qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, 102218, China

Location

MeSH Terms

Conditions

Choledochal Cyst

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Shuo Jin, PhD

  Beijing Tsinghua Chang Gung Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 19, 2025
• Study Start: January 1, 2024
• Primary Completion: July 30, 2025
• Study Completion: October 15, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)