RecruitingNCT07007832

Bile Omics for Diagnosing Indeterminate Biliary Strictures

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

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Enrollment

260 participants

Start Date

Jan 1, 2024

Study Type

OBSERVATIONAL

Conditions

Pancreatic Cancer Cholangiocarcinoma Gallbladder Cancer and Extrahepatic Cholangiocarcinoma Bile Duct Strictures of Unknown Origin Bile Duct Strictures

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

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is examining bile (digestive fluid from the liver) to look for markers that can help diagnose "indeterminate biliary strictures" — narrowings in the bile ducts that are unclear on standard tests and may or may not be cancerous. Better testing could reduce the need for invasive procedures. **You may be eligible if...** - You are between 18 and 90 years old - You have been found to have an indeterminate biliary stricture (a bile duct narrowing with unclear cause) - You have undergone or are scheduled for an ERCP (a procedure to examine the bile ducts) with biopsy and/or brush sampling **You may NOT be eligible if...** - You have a blood clotting disorder - You are pregnant - You have cancer in another organ unrelated to the bile ducts - You declined to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEndoscopic 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.