Bile Omics for Diagnosing Indeterminate Biliary Strictures

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.

NCT Number	NCT07007832
Lead Sponsor	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Collaborators: Eastern Hepatobiliary Surgery Hospital, Shanghai 6th People's Hospital
Conditions	Cholangiocarcinoma, Gallbladder Cancer and Extrahepatic Cholangiocarcinoma, Pancreatic Cancer, Bile Duct Strictures of Unknown Origin, Bile Duct Strictures
Enrollment	260 participants
Start Date	2024-01-01
Primary Completion	2026-12-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-06-11