Clinical trial Recruiting at 1 site Observational Ages 18 to 90

Using bile analysis to diagnose unclear narrowings of the bile ducts

Official title: The Diagnostic Value of Bile-based Omics Analysis for Indeterminate Biliary Strictures

Run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · NCT07007832 · Data updated 2026-11-12

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.

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Quick facts

Study typeObservational
Ages18 Years to 90 Years
SexAll
Enrollment260 (estimated)
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Academic / other
Locations1 site (Shanghai, China)
StatusRecruiting
StartedJanuary 1, 2024
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedJune 11, 2025
Trial IDNCT07007832 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–90 with indeterminate biliary strictures who undergo ERCP with biliary biopsy and/or brush cytology are the intended participants.

Probably not a fit

Patients with coagulation disorders, pregnancy, unrelated malignancies, or those who decline participation are excluded and would not benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
    Shanghai, China, China
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.