Cohort study on biliary dilatation 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 trying to gather information from patients with bile duct dilatation across China to better understand the condition, its risks, and the best timing for surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6000 (estimated) |
| Ages | N/A to 80 Years |
| Sex | All |
| Sponsor | Beijing Tsinghua Chang Gung Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06881004 on ClinicalTrials.gov |
What this trial studies
This multicenter cohort study aims to continuously enroll patients with biliary dilatation from 25 medical centers across China. It will collect comprehensive data on demographics, clinical characteristics, and long-term outcomes to establish a national cohort for bile duct dilatation. The study seeks to clarify the epidemiological and pathological features of the condition, assess cancer risks, and determine optimal surgical intervention timing. Additionally, it will compare perioperative risks and quality of life among different patient types following surgical treatment.
Who should consider this trial
Good fit: Ideal candidates include patients aged 0 to 80 years who have been definitively diagnosed with biliary dilation.
Not a fit: Patients with conditions unrelated to biliary dilation or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical strategies and better long-term outcomes for patients with biliary dilatation.
How similar studies have performed: While similar cohort studies have been conducted, this specific approach to establishing a national cohort for biliary dilatation in China is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing, Beijing Municipality
- Beijing Tsinghua Chang Gung Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Shuo Jin, PhD — Beijing Tsinghua Chang Gung Hospital
- Study coordinator: Changzhen Yang, MD
- Email: 809262038@qq.com
- Phone: +8618810915262
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.