NCT06881004

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
108mo left

Started Mar 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Mar 2025Mar 2035

First Submitted

Initial submission to the registry

March 11, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

March 19, 2025

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2035

Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

10 years

First QC Date

March 11, 2025

Last Update Submit

May 9, 2025

Conditions

Choledochal Cyst

Keywords

Biliary dilatationCohort studyClinical databaseSurgical treatmentLong-term outcome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Malignant transformation rate

    through study completion, an average of 10 year

  • Perioperative complication rate

    Within 30 or 90 days postoperatively

Study Arms (2)

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.

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, 102218, China

RECRUITING

MeSH Terms

Conditions

Choledochal Cyst

Condition Hierarchy (Ancestors)

CystsNeoplasmsBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesDigestive System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Shuo Jin, PhD

    Beijing Tsinghua Chang Gung Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Changzhen Yang, MD

CONTACT

+8618810915262809262038@qq.com

Shuo Jin, PhD

CONTACT

+8618611172714jsa01263@btch.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief Physician

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 18, 2025

Study Start

March 19, 2025

Primary Completion (Estimated)

March 31, 2035

Study Completion (Estimated)

March 31, 2035

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)