Using bile analysis to diagnose unclear narrowings of the bile ducts
The Diagnostic Value of Bile-based Omics Analysis for Indeterminate Biliary Strictures
This project will test whether analyzing bile with molecular 'omics' together with routine biliary brushings or biopsies can help find cancer in people with indeterminate biliary strictures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 260 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai, China) |
| Trial ID | NCT07007832 on ClinicalTrials.gov |
What this trial studies
This observational study collects bile samples from adults with indeterminate biliary strictures at the time of ERCP and pairs those samples with biliary brush cytology and/or biopsy. Researchers will perform multi-omics screening on bile to identify molecular markers linked to biliary and pancreatic malignancies. Promising markers will be validated and used to build a bile-based molecular diagnostic model. The goal is to determine whether adding bile omics to current tissue sampling improves diagnostic sensitivity for malignant strictures.
Who should consider this trial
Good fit: Adults aged 18–90 with indeterminate biliary strictures who undergo ERCP with biliary biopsy and/or brush cytology are the intended participants.
Not a fit: Patients with coagulation disorders, pregnancy, unrelated malignancies, or those who decline participation are excluded and would not benefit from participation.
Why it matters
Potential benefit: If successful, the approach could produce a bile-based test that helps detect biliary cancers more accurately and earlier than current methods alone.
How similar studies have performed: Prior bile-based molecular tests have reported improved detection rates, but combining multi-omics analysis with biliary cytology/biopsy for a diagnostic model is novel and has not been previously reported.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shanghai, China
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China, China (Recruiting)
Study contacts
- Study coordinator: Xiaobo Cai, MD
- Email: caixiaobo1979@hotmail.com
- Phone: 86+13918177123
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.