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RECRUITING
NCT07007832

Bile Omics for Diagnosing Indeterminate Biliary Strictures

Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

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.

Official title: The Diagnostic Value of Bile-based Omics Analysis for Indeterminate Biliary Strictures

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

OBSERVATIONAL

Enrollment

260

Start Date

2024-01-01

Completion Date

2026-12-31

Last Updated

2025-06-11

Healthy Volunteers

No

Interventions

PROCEDURE

Endoscopic retrograde cholangiopancreatography

Since patients with biliary strictures almost universally require endoscopic biliary interventions for both diagnostic and drainage purposes, bile aspiration can be readily obtained during these procedures, facilitating subsequent analyses. However, proteomic and metabolomic profiling of bile in malignant biliary strictures remains unreported to date. This study aims to evaluate the diagnostic value of combining bile proteomics/metabolomics with biliary brush cytology/biopsy for malignant biliary strictures, while also providing evidence for identifying potential biomarkers.

Locations (1)

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China, China