Bile Omics for Diagnosing Indeterminate Biliary Strictures

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine260 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

260

Conditions

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

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Diagnostic sensitivity

Time frame: histologically or cytogically confirmed , or followed up for 6 months

Secondary Outcomes

accuracy

Time frame: histologically or cytologically confirmed or followed up for 6 months

Specificity

Time frame: histologically or cytologically confirmed or followed up for 6 months

Positive predictive value,

Time frame: histologically or cytologically confirmed or followed up for 6 months

negative predictive value

Time frame: histologically or cytologically confirmed or followed up for 6 months

AUC area (histologically or cytologically confirmed or followed up for 6 months)

Time frame: up for 6 months

Bile Omics for Diagnosing Indeterminate Biliary Strictures

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts