Clinical trialObsRecruiting
Bile Omics for Diagnosing Indeterminate Biliary Strictures
The Diagnostic Value of Bile-based Omics Analysis for Indeterminate Biliary Strictures
- Outcome
- Ongoing
- Phase
- Obs
- Status
- Recruiting
- Study type
- Observational
- Start
- 1 January 2024
- Expected end
- 31 December 2026
- Enrollment
- 260 participants
- Sites
- 1
- Primary outcomes
- Diagnostic sensitivity
- Sponsor
- Other
- Results posted
- No
- Last update
- 11 June 2025
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Brief summary public domain (ClinicalTrials.gov)
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.
Intervention public domain (ClinicalTrials.gov)
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.
Arm public domain (ClinicalTrials.gov)
indeterminate biliary strictures (): Pathologically or clinical confirmed
Primary outcome public domain (ClinicalTrials.gov)
Diagnostic sensitivity. Time frame: histologically or cytogically confirmed , or followed up for 6 months.
Secondary outcome public domain (ClinicalTrials.gov)
accuracy. Time frame: histologically or cytologically confirmed or followed up for 6 months.
Secondary outcome public domain (ClinicalTrials.gov)
Specificity. Time frame: histologically or cytologically confirmed or followed up for 6 months.
Secondary outcome public domain (ClinicalTrials.gov)
Positive predictive value,. Time frame: histologically or cytologically confirmed or followed up for 6 months.
Secondary outcome public domain (ClinicalTrials.gov)
negative predictive value. Time frame: histologically or cytologically confirmed or followed up for 6 months.
Secondary outcome public domain (ClinicalTrials.gov)
AUC area (histologically or cytologically confirmed or followed up for 6 months). Time frame: up for 6 months.
Eligibility public domain (ClinicalTrials.gov)
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
Enrollment public domain (ClinicalTrials.gov)
Enrollment: 260 participants (estimated).