IMPROVING THE DIAGNOSTIC ACCURACY OF SINGLE-OPERATOR CHOLANGIOSCOPY
Research type
Research Study
Full title
IMPROVING THE DIAGNOSTIC ACCURACY OF DIGITAL SINGLE-OPERATOR CHOLANGIOSCOPY FOR INDETERMINATE BILIARY STRICTURES:
IRAS ID
257606
Contact name
George Goodchild
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2019/08/125, UCL Data Protection Office Registration
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Traditional diagnostic tests for detection of bile duct cancer have low pick up rates. Single-operator cholangioscopy (placing a flexible camera (or endoscope) into the bile duct) has shown promising results when other tests have failed to pick up a suspected cancer. It has been suggested that the appearance of the bile duct abnormality at the time of the endoscopy (camera test) might be more accurate in detecting cancer that the subsequent biopsy results. However, in previous studies the person doing the test knew the patients medical history and previous test results, therefore they were likely to be biased when they were visually assessing the stricture. Furthermore, biopsy protocols and tissue sampling techniques have not yet been systematically investigated therefore we still don't know the best biopsy method to use in order to increase the chance of picking up cancerous cells. We therefore aim to identify and validate endoscopic criteria for the diagnosis of cancerous biliary strictures bile duct cancer, in a representative study population with a high pre-test probability of cancer, while blinding the reviewing endoscopists for previous investigation results. In addition, the diagnostic accuracy of tissue sampling by taking multiple biopsies and using a tunnelled technique (taking biopsies from the same area) will be investigated.
This application applies to the UK arm only of a project that forms part of a European Study.REC name
London - Dulwich Research Ethics Committee
REC reference
19/LO/1794
Date of REC Opinion
22 Jan 2020
REC opinion
Further Information Favourable Opinion