Clinical trial · Observational
Congenital Biliary Dilatation Diagnosis Based on 3D Morphological Characteristics
NCT06162520CI-TRIAL-00072078completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
Congenital biliary dilatation necessitates timely intervention owing to potential complications. This study endeavors to enhance diagnostic precision using quantitative three-dimensional morphological characteristics. Objectives involve developing models to differentiate congenital from secondary biliary dilatation and identify intrahepatic involvement. Employing machine learning, robust diagnostic models aim to elevate clinical detection rates and improve accuracy.
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 |
|---|---|---|---|
| Congenital Biliary Dilatation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast-enhanced computed tomography (CECT) and 3D morphological analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Congenital biliary dilatation
- description
- Patients with congenital biliary dilatation diagnosed according to the Japanese Study Group on Congenital Biliary Dilatation (JSCBD) guideline.
- interventionNames
- Other: Contrast-enhanced computed tomography (CECT) and 3D morphological analysis
- label
- Secondary biliary dilatation
- description
- Patients with secondary biliary dilatation attributed to choledocholithiasis or malignancies (hilar cholangiocarcinoma, pancreatic carcinoma, and distal cholangiocarcinoma).
- interventionNames
- Other: Contrast-enhanced computed tomography (CECT) and 3D morphological analysis
Primary outcomes (1)
- measure
- Area under the Receiver Operating Characteristic curve (AUROC) of the diagnostic models for the differential diagnosis of congenital and secondary biliary dilatation and the identification of intrahepatic involvement
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * The patients with biliary dilation who underwent contrast-enhanced computed tomography (CECT) at Beijing Tsinghua Chang Gung Hospital from 2014 to 2022. Exclusion Criteria: * Patients without pre-operative CECT scans or developing cholangiocarcinoma due to congenital biliary dilatation.
References
Publications (2)
- BACKGROUNDIshibashi H, Shimada M, Kamisawa T, Fujii H, Hamada Y, Kubota M, Urushihara N, Endo I, Nio M, Taguchi T, Ando H; Japanese Study Group on Congenital Biliary Dilatation (JSCBD). Japanese clinical practice guidelines for congenital biliary dilatation. J Hepatobiliary Pancreat Sci. 2017 Jan;24(1):1-16. doi: 10.1002/jhbp.415. Epub 2017 Jan 22. PMID 28111910
- DERIVEDDou J, Jiang N, Zeng J, Wang S, Tian S, Shan S, Li Y, Xu Z, Lin X, Jin S, Dong J, Chen H. Novel 3D morphological characteristics for congenital biliary dilatation diagnosis: a case-control study. Int J Surg. 2024 May 1;110(5):2614-2624. doi: 10.1097/JS9.0000000000001204. PMID 38376858