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RECRUITINGOBSERVATIONAL

Bile Omics for Diagnosing Indeterminate Biliary Strictures

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Indeterminate biliary strictures - Aged 18-90 years - Underwent ERCP with biliary biopsy and/or brush cytology Who Should NOT Join This Trial: - Coagulation disorders - Pregnancy - Malignancies of other organs unrelated to biliary strictures - Declined participation Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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