Bile Omics for Diagnosing Indeterminate Biliary Strictures

Shanghai Jiao Tong University

Status: Enrolling

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

Treatments: Procedure: Endoscopic retrograde cholangiopancreatography

Study type: Observational

Funder types: Other

Identifiers

NCT07007832

[2025] No. 236

Details and patient eligibility

About

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.

Enrollment: 260 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

260 participants in 1 patient group

indeterminate biliary strictures

Description:

Pathologically or clinical confirmed

Treatment:

Procedure: Endoscopic retrograde cholangiopancreatography