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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 260 (estimated) |
| Sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai, China) |
| Status | Recruiting |
| Started | January 1, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | June 11, 2025 |
| Trial ID | NCT07007832 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
- Study coordinator: Xiaobo Cai, MD
- Email: caixiaobo1979@hotmail.com
- Phone: 86+13918177123
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
68Ga-SorB PET/CT imaging for solid tumors
This study tests a new PET tracer called 68Ga-SorB to see if it can safely and accurately detect tumors in adults with melanoma, liver, lung, breast, pancreatic, ovarian cancer, or cholangiocarcinoma.
-
CAIX-targeted 18F-T2 PET/CT imaging in solid tumors
This study tests a CAIX-specific radioactive tracer to see if PET/CT can help visualize solid tumors and checks safety and radiation exposure in adults with certain cancers.
-
In-depth characterisation of biliary strictures and hepato‑pancreato‑biliary focal lesions to support new diagnostic technologies
This project will collect detailed imaging and tissue data from adults with suspected bile duct, liver, pancreatic, or gallbladder lesions to help develop and test better diagnostic tools.
-
Tissue adhesive (Glubran®2) to reinforce pancreaticojejunostomy in soft pancreas
This trial will test whether adding a tissue adhesive glue (Glubran®2) to the pancreatic-jejunal connection reduces postoperative pancreatic leaks in adults with a soft pancreas undergoing pancreaticoduodenectomy.
-
Testing MDX2001 for advanced solid tumors
This study is testing a new drug called MDX2001 to see if it can safely help people with advanced solid tumors like breast or colon cancer.
-
Comparing blood samples from cancer-draining veins to standard veins in patients with liver and pancreatic cancers
This study is testing if taking blood samples from veins near liver and pancreatic tumors can help find cancer DNA better than using regular veins in patients getting biopsies.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.