The VIRTUOSO study (Version 1.0)
Research type
Research Study
Full title
A Comparison Of High Definition White Light Endoscopy And High Definition Virtual Chromoendoscopy For The Detection Of Intraepithelial Neoplasia In Longstanding Colitis: A Randomised Control Trial\n(VIRTUOSO Study)\n
IRAS ID
188579
Contact name
Pradeep Bhandari
Sponsor organisation
Portsmouth Hospital NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 0 days
Research summary
The colon (large bowel) is the last part of the gut that processes waste for elimination as faeces. Colitis, an inflammation of the colon, can be caused by ulcerative colitis and Crohn’s disease. Presence of colitis for more than 8 years increases the risk of developing colon cancer. To prevent cancers developing, patients have a surveillance colonoscopy (using a colonoscope which is a thin flexible tube used to look inside the colon), to find pre-cancerous changes. During the colonoscopy, 4 tissue samples (biopsies) every 10 centimetres of the bowel and biopsies of any abnormal appearing areas are taken. \n\nHistoric studies showed that spraying dyes (eg. indigo carmine) highlight these abnormal areas for the endoscopist to remove. However, there are weaknesses to this technique: studies used older endoscope technologies with poor image quality, and using dye spray adds to the total time taken for a colonoscopy. Subsequently, dye spray colonoscopy has not been widely adopted. \n\nModern generation colonoscopes provide better images with high definition white light (HDWL). HDWL has been shown to be able to detect abnormal areas in the colon as effectively as the dye spray technique. A new technology, ‘virtual chromoendoscopy’(HDV), uses different types of lights to highlight abnormal areas on the bowel surface. Studies have shown that HDV is good at finding abnormal areas in the colon. However, there are no studies comparing HDV with HDWL. If HDV can be shown to be more effective than HDWL, then it could be an alternative to the dye spray technique.\n\nIn this single centre study, 204 patients referred for routine surveillance colonoscopy will be randomly assigned to have a colonoscopy using either HDWL or HDV. All patients will also have 4 biopsies for every 10 centimetres of bowel. The study is expected to take 14 months to complete.\n
REC name
South Central - Oxford A Research Ethics Committee
REC reference
16/SC/0116
Date of REC Opinion
3 May 2016
REC opinion
Further Information Favourable Opinion