Actively Recruiting

Age: 16Years +
All Genders
ID07206355

In-Depth Characterisation of Biliary Strictures and Hepato-Pancreato-Biliary Focal Lesions for Development of New Technologies to Tackle Hepato-Pancreato-Biliary Cancers

Led by University of Nottingham · Updated on 2026-04-29

160

Participants Needed

1

Research Sites

104 weeks

Total Duration

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AI-Summary

What this Trial Is About

Hepato-Pancreato-Biliary (HPB) cancers, including those in the liver, bile ducts, pancreas, and gall bladder, pose a growing health challenge with rising incidence and low survival rates. Cholangiocarcinoma and pancreatic cancer are often diagnosed late due to vague symptoms and difficulties in imaging and tissue sampling. Accurate diagnosis is complicated by anatomical challenges and the similarity between benign and malignant lesions. This study aims to better understand the clinical and molecular characteristics of liver and pancreatic biliary focal lesions to improve diagnosis and treatment, supported by advanced technologies and molecular profiling. This observational study involves patients undergoing standard care investigations or surgical resections for HPB focal lesions or biliary strictures. Investigations include endoscopic ultrasound with fine needle tissue sampling, endoscopic retrograde cholangiopancreatography, cholangioscopy, and percutaneous sampling. Surplus tissue and body fluids such as bile and cyst fluid, as well as blood samples, are collected during routine clinical procedures for research purposes without increasing patient risk. The study will also use advanced imaging like Raman spectroscopy and develop a bioresource from collected samples. Participants will have tissue and fluid samples collected alongside their usual care, with data gathered over a 60-month period. Researchers will assess the adequacy of tissue samples for diagnosis and molecular characterization, correlate advanced imaging results with standard pathology, and identify genetic markers for early diagnosis. The study aims to create a detailed database and image library to support new diagnostic and treatment tools. Patient safety and standard care continue throughout, with no additional clinical risks from research sample collection.

CONDITIONS

Brief Title

In-Depth Characterisation of Biliary Strictures and Hepato-Pancreato-Biliary Focal Lesions for Development of New Technologies to Tackle Hepato-Pancreato-Biliary Cancers

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 16 years and over
  • Ability to provide informed consent to participate in the study
  • Patients attending Nottingham University Hospitals NHS Trust as part of standard clinical care for:
    • Diagnosis and treatment of suspected biliary stricture or any focal lesion in the Hepato-Pancreato-Biliary tract, including liver or pancreatic lesion or pancreatic cyst
    • Surgical resection treatment of liver, pancreas, or gall bladder including Whipple Procedure, gall bladder resection, or hepatic resection
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Varies based on clinical care

Participants undergo investigations as part of their standard clinical care to diagnose and characterize biliary strictures and hepato-pancreato-biliary focal lesions. Investigations may include endoscopic ultrasound, fine needle tissue acquisition, endoscopic retrograde cholangio-pancreatography, cholangioscopy, or percutaneous sampling.

1 to multiple visits depending on diagnostic procedures

Surgical Treatment

Duration - Varies based on surgical procedure and recovery

Participants undergoing surgical resection of liver, pancreas, gallbladder, or bile duct as part of standard care for treatment of underlying conditions.

1 surgical visit and subsequent hospital stay

Long-term Monitoring

Duration - Up to 3 years

Participants are followed over time to collect data and samples for characterizing biliary strictures and HPB focal lesions, developing a tissue bioresource, and creating a library of images and genetic markers.

Trial Site Locations

Total: 1 location

1

University of Nottingham

Nottingham, United Kingdom

Actively Recruiting

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Research Team

S

Saikat Mandal, MBBS, MD, MRCEM

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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