In-depth characterisation of biliary strictures and hepato‑pancreato‑biliary focal lesions to support new diagnostic technologies
In-Depth Characterisation of Biliary Strictures and Hepato-Pancreato-Biliary Focal Lesions for Development of New Technologies to Tackle Hepato-Pancreato-Biliary Cancers
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | University of Nottingham Academic / other |
| Locations | 1 site (Nottingham) |
| Trial ID | NCT07206355 on ClinicalTrials.gov |
What this trial studies
This observational project will enroll adults (≥16) attending Nottingham University Hospitals with suspected biliary strictures or other hepato‑pancreato‑biliary (HPB) focal lesions, including those undergoing surgical resection. It will collect clinical information, imaging, endoscopic and surgical tissue samples, and linked pathology and molecular profiling obtained as part of routine care. The aim is to characterise features that distinguish benign from malignant lesions and to provide well‑annotated material for development of imaging, sampling, and molecular diagnostic technologies. No experimental treatments are given; participation involves consenting to use of data and samples collected during standard diagnosis and treatment.
Who should consider this trial
Good fit: Adults aged 16 and over who are attending Nottingham University Hospitals for diagnosis or surgical treatment of suspected biliary strictures or other HPB focal lesions are ideal candidates.
Not a fit: People without suspected HPB lesions, those not having tissue sampling or diagnostic imaging as part of care, or patients treated outside Nottingham are unlikely to receive direct benefit from participating.
Why it matters
Potential benefit: If successful, this work could enable earlier and more accurate diagnosis of HPB cancers and improve matching of patients to targeted therapies.
How similar studies have performed: Prior research has identified actionable molecular targets in cholangiocarcinoma and pancreatic cancer, but comprehensive paired imaging, tissue, and molecular datasets specifically collected to drive new diagnostic devices are relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 16 years and over * Ability to provide informed consent to participate in the study * Patients attending Nottingham University Hospitals NHS Trust (NUH) as part of standard clinical care for either: * the diagnosis and treatment of suspected biliary stricture or any focal lesion in the Hepato-Pancreato-Biliary (HPB) tract (clinically / radiologically) including liver or pancreatic lesion or pancreatic cyst * surgical resection treatment of liver, pancreas, or gall bladder including Whipple Procedure (pancreaticoduodenectomy surgery), gall bladder resection (cholecystectomy), hepatic resection Exclusion Criteria: No exclusion criteria
Where this trial is running
Nottingham
- University of Nottingham — Nottingham, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Guruprasad P Aithal, MBBS, MD, PhD — University of Nottingham
- Study coordinator: Saikat Mandal, MBBS, MD, MRCEM
- Email: saikat.mandal@nottingham.ac.uk
- Phone: (+44) 0115 970 9900
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.