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NCT Number: NCT06881004

Biliary Dilatation National Special Disease Cohort in China

This study is a multicenter, bidirectional cohort study aimed at continuously enrolling patients with biliary dilatation from 25 medical centers in China. It will collect comprehensive life-cycle data from the cohort to establish a Chinese cohort for bile duct dilatation. Based on this cohort, the study seeks to clarify the epidemiological characteristics, pathological features, standard classification, disease progression, cancer risk, and optimal timing for surgical intervention in patients with bile duct dilatation. Additionally, it will compare the perioperative risks, long-term outcomes, and quality of life among different types of patients (including Todani types I, IVa, and V) following surgical treatment, to establish standardized surgical treatment strategies for each type.

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Key information

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Biliary Dilatation(BD) is a complex benign biliary disorder prevalent in East Asia, for which surgical resection remains the sole curative approach necessitating prompt intervention upon diagnosis. Nevertheless, critical aspects including disease subtyping, standardized surgical management protocols, and prognostic determinants remain inadequately defined. This multicenter ambidirectional cohort study aims to consecutively enroll BD patients across 25 tertiary medical centers in China, systematically collecting comprehensive life-cycle data encompassing demographic profiles, clinical baseline characteristics, laboratory/imaging findings, biliary-specific biomarkers, and longitudinal follow-up records to establish a nationally representative Chinese BD cohort. Building upon this cohort, the study objectives are structured as follows:

  • Establishment and Maintenance: To construct and perpetually update a multicenter clinical database for BD research in China, ensuring data integrity and accessibility.
  • Age-Stratified Comparative Analysis: To delineate and contrast the differential patterns of disease progression, surgical decision-making paradigms, and postoperative surveillance strategies between adult and pediatric BD populations.
  • Natural History Characterization: To elucidate disease trajectories, morphological evolution, comorbidity progression, malignant transformation risks, and evidence-based surgical indications/timing in non-operated asymptomatic BD patients.
  • Therapeutic Standardization: To define optimal surgical modalities (with emphasis on Todani classification types I, IVa, and V) and critically evaluate the efficacy-safety profile of standardized operative approaches through multidimensional outcome assessments.
  • Quality-of-Life Quantification: To systematically evaluate postoperative quality of life (QoL) metrics across BD subtypes and identify modifiable determinants influencing long-term patient-reported outcomes.
  • Epidemiological Benchmarking: To synthesize epidemiological patterns, establish evidence-based clinical endpoints for surgical interventions, and define reference standards for treatment-related risks and QoL benchmarks in standardized BD management.

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

  • None

Treatment and study plan

Primary outcomes

  1. Long-term complications rate

    Time frame: After 30 or 90 days of surgery

    For patients who have undergone surgical treatment, 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 10 year

    The occurrence of malignant transformation associated with bile duct dilatation

  2. Perioperative complication rate

    Time frame: Within 30 or 90 days postoperatively

    The occurrence of perioperative complications, including bile leakage, pancreatic leakage, liver failure, bacteremia, abdominal fluid accumulation, and intra-abdominal infections, among others.

Study contacts

Contact information is provided by the study sponsor or research team.

Changzhen Yang, MD

CONTACT

[email protected]

+8618810915262

Shuo Jin, PhD

CONTACT

[email protected]

+8618611172714

Sponsors and collaborators

Lead sponsor

Beijing Tsinghua Chang Gung Hospital

Other

Registry information

Official study title

Establishment and Evaluation of Clinical Classification and Surgical Decision-making System for Biliary Dilatation:a National Special Disease Cohort Study in China

Important dates

Study start
2025
Primary completion
2035
Study completion
2035
First posted
Mar 18, 2025
Registry last updated
Jun 23, 2026

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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