Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Choledochal Cyst | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Retrospective cohort
- description
- 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.
- label
- Prospective cohort
- description
- 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.
Primary outcomes (1)
- measure
- Long-term complications rate
- timeFrame
- After 30 or 90 days of surgery
- description
- 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 (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available