Bile Omics for Diagnosing Indeterminate Biliary Strictures

Recruiting

• Conditions: Cholangiocarcinoma; Gallbladder Cancer and Extrahepatic Cholangiocarcinoma; Pancreatic Cancer; Bile Duct Strictures; Bile Duct Strictures of Unknown Origin

• Registration Number: NCT07007832
• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

The diagnosis of malignant biliary strictures remains a challenging aspect of biliary endoscopy. Molecular biological testing techniques based on bile have been reported to improve detection rates. However, whether the combination of bile-based omics studies and biliary brush cytology/biopsy can enhance diagnostic sensitivity has not yet been reported. This study aims to collect bile from patients with malignant biliary strictures, screen for molecular markers associated with biliary malignancies through multi-omics analysis, and subsequently validate these markers to establish a bile-based molecular diagnostic model.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2025-05-29
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-05
• Study First Posted: 2025-06-06
• Last Update Submitted: 2025-06-07
• Last Update Posted: 2025-06-11
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

• Indeterminate biliary strictures
• Aged 18-90 years
• Underwent ERCP with biliary biopsy and/or brush cytology

Exclusion Criteria

• Coagulation disorders
• Pregnancy
• Malignancies of other organs unrelated to biliary strictures
• Declined participation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic sensitivity	histologically or cytogically confirmed , or followed up for 6 months

Secondary Outcome Measures

Name	Time	Method
Positive predictive value,	histologically or cytologically confirmed or followed up for 6 months
negative predictive value	histologically or cytologically confirmed or followed up for 6 months
AUC area (histologically or cytologically confirmed or followed up for 6 months)	up for 6 months
accuracy	histologically or cytologically confirmed or followed up for 6 months
Specificity	histologically or cytologically confirmed or followed up for 6 months

Trial Locations

Locations (1)

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China