Biliary Dilatation National Special Disease Cohort in China

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

Study Overview

• Status: Recruiting
• Conditions: Choledochal Cyst

Detailed Description

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:

1. Establishment and Maintenance: To construct and perpetually update a multicenter clinical database for BD research in China, ensuring data integrity and accessibility.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.

• Study Type: Observational
• Enrollment (Estimated): 6000

Contacts and Locations

• Study Contact: Name: Changzhen Yang, MD; Phone Number: +8618810915262; Email: 809262038@qq.com
• Study Contact Backup: Name: Shuo Jin, PhD; Phone Number: +8618611172714; Email: jsa01263@btch.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 102218
      • Recruiting
      • Beijing Tsinghua Chang Gung Hospital
      • Contact: Changzhen Yang, MD; Phone Number: +8618810915262; Email: 809262038@qq.com
      • Contact: Shuo Jin, PhD; Phone Number: +8618611172714; Email: jsa01263@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Retrospective cohort; This cohort retrospectively collects all available clinical data and prognostic information of all patients who were previously diagnosed with 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term complications rate	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.	After 30 or 90 days of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Malignant transformation rate	The occurrence of malignant transformation associated with bile duct dilatation	through study completion, an average of 10 year
Perioperative complication rate	The occurrence of perioperative complications, including bile leakage, pancreatic leakage, liver failure, bacteremia, abdominal fluid accumulation, and intra-abdominal infections, among others.	Within 30 or 90 days postoperatively

Collaborators and Investigators

• Sponsor: Beijing Tsinghua Chang Gung Hospital
• Investigators: Principal Investigator: Shuo Jin, PhD, Beijing Tsinghua Chang Gung Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2025
• Primary Completion (Estimated): March 31, 2035
• Study Completion (Estimated): March 31, 2035

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 18, 2025

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 9, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Cohort study; Long-term outcome; Surgical treatment; Biliary dilatation; Clinical database
• Additional Relevant MeSH Terms: Neoplasms; Pathological Conditions, Anatomical; Digestive System Diseases; Biliary Tract Diseases; Congenital Abnormalities; Cysts; Bile Duct Diseases; Digestive System Abnormalities; Dilatation, Pathologic; Choledochal Cyst
• Other Study ID Numbers: 24640-0-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No