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NCT Number: NCT07028164

Clinical Features and Prognosis 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.

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Key information

Conditions

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

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, 102218, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Malignant transformation rate

    Time frame: Through study completion, an average of 5 year

    The occurrence of malignant transformation associated with bile duct dilatation.

Other outcomes

  1. Mayo Score

    Time frame: Through study completion, an average of 5 year

    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.

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

    Time frame: Through study completion, an average of 5 year

    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.

Sponsors and collaborators

Lead sponsor

Beijing Tsinghua Chang Gung Hospital

Other

Registry information

Official study title

Epidemiology, Prognosis, and Treatment Effectiveness of Asymptomatic Biliary Dilatation

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 19, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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