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Bile Omics for Diagnosing Indeterminate Biliary Strictures

RECRUITINGSponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Actively Recruiting
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Started2024-01-01
Est. completion2026-12-31
Eligibility
Age18 Years – 90 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07007832

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

Age: 18 Years – 90 YearsHealthy volunteers accepted
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

Conditions6

Bile Duct StricturesBile Duct Strictures of Unknown OriginCancerCholangiocarcinomaGallbladder Cancer and Extrahepatic CholangiocarcinomaPancreatic Cancer

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