Trials / Recruiting
RecruitingNCT07007832
Bile Omics for Diagnosing Indeterminate Biliary Strictures
The Diagnostic Value of Bile-based Omics Analysis for Indeterminate Biliary Strictures
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 260 (estimated)
- Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Cholangiocarcinoma
- Gallbladder Cancer and Extrahepatic Cholangiocarcinoma
- Pancreatic Cancer
- Bile Duct Strictures of Unknown Origin
- Bile Duct Strictures
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | 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. |
Timeline
- Start date
- 2024-01-01
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
- First posted
- 2025-06-06
- Last updated
- 2025-06-11
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07007832. Inclusion in this directory is not an endorsement.