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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Tsinghua Chang Gung Hospital
RECRUITING
Beijing
Contact Information
Primary
Changzhen Yang, MD
809262038@qq.com
+8618810915262
Backup
Shuo Jin, PhD
jsa01263@btch.edu.cn
+8618611172714
Time Frame
Start Date: 2025-03-19
Estimated Completion Date: 2035-03-31
Participants
Target number of participants: 6000
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Beijing Tsinghua Chang Gung Hospital

This content was sourced from clinicaltrials.gov