Bile Omics for Diagnosing Indeterminate Biliary Strictures

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Diagnostic sensitivity — histologically or cytogically confirmed , or followed up for 6 months

Trial sites (1)

More Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine trials in China

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