Congenital Biliary Dilatation Diagnosis Based on 3D Morphological Characteristics

NCT06162520 | Completed DMC

• 1 other identifier: 21445-4-01
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

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

Congenital Biliary Dilatation

Outcome Measures

Primary Outcomes (1)

• 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

  The area under the ROC curve is calculated by integrating the ROC curve, which plots Sensitivity against 1 - Specificity.

  Pre-operation

Secondary Outcomes (4)

• Area under the Precision-Recall curve (AUPRC) of the diagnostic models for the differential diagnosis of congenital and secondary biliary dilatation and the identification of intrahepatic involvement

  Pre-operation

• Sensitivity of the diagnostic models for the differential diagnosis of congenital and secondary biliary dilatation and the identification of intrahepatic involvement

  Pre-operation

• Specificity of the diagnostic models for the differential diagnosis of congenital and secondary biliary dilatation and the identification of intrahepatic involvement

  Pre-operation

• Accuracy of the diagnostic models for the differential diagnosis of congenital and secondary biliary dilatation and the identification of intrahepatic involvement

  Pre-operation

Study Arms (2)

Congenital biliary dilatation

Patients with congenital biliary dilatation diagnosed according to the Japanese Study Group on Congenital Biliary Dilatation (JSCBD) guideline.

Other: Contrast-enhanced computed tomography (CECT) and 3D morphological analysis

Secondary biliary dilatation

Patients with secondary biliary dilatation attributed to choledocholithiasis or malignancies (hilar cholangiocarcinoma, pancreatic carcinoma, and distal cholangiocarcinoma).

Other: Contrast-enhanced computed tomography (CECT) and 3D morphological analysis

Interventions

Contrast-enhanced computed tomography (CECT) and 3D morphological analysis OTHER

Diagnosis models are established using quantitative morphological characteristics extracted from the 3D reconstructed bile duct from contrast-enhanced computed tomography (CECT) images.

Congenital biliary dilatation; Secondary biliary dilatation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with congenital biliary dilatation diagnosed according to the Japanese Study Group on Congenital Biliary Dilatation (JSCBD) guideline or secondary bile duct dilatation due to choledocholithiasis or malignancies such as hilar cholangiocarcinoma, pancreatic carcinoma, and distal cholangiocarcinoma who underwent contrast-enhanced computed tomography (CECT) at Beijing Tsinghua Chang Gung Hospital from 2014 to 2022.

You may qualify if:

• The patients with biliary dilation who underwent contrast-enhanced computed tomography (CECT) at Beijing Tsinghua Chang Gung Hospital from 2014 to 2022.

You may not qualify if:

• Patients without pre-operative CECT scans or developing cholangiocarcinoma due to congenital biliary dilatation.

Sponsors & Collaborators

• Tsinghua University: lead
• Beijing Tsinghua Chang Gung Hospital: collaborator

Study Sites (1)

Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, 102218, China

Location

Related Publications (2)

• Ishibashi 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 BACKGROUND

• Dou 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 DERIVED

MeSH Terms

Conditions

Choledochal Cyst

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Huijun Chen, Ph.D.

  Tsinghua University

  STUDY DIRECTOR

• Jiahong Dong, M.D.

  Beijing Tsinghua Chang Gung Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 8, 2023
• Study Start: December 17, 2021
• Primary Completion: December 16, 2022
• Study Completion: December 16, 2022
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)