Research details

Lead name: Rupert Jackson ([email protected])

Research theme: Lower GI

Study region: Great Britain

Start / Expected Start Date: 2024-04-01

End / Expected End Date: 2027-09-30

Funding source: NIHR Health Technology Assessment (HTA) Programme

Study status: Active

Research Summary

Lower gastrointestinal symptoms attributed to colorectal disease are common. Early diagnosis of serious colorectal disease such as colorectal cancer (CRC), precancerous growths (polyps) and inflammation is important to ensure the best possible outcomes for a patient. The current ‘gold standard’ diagnostic test is colonoscopy. Colonoscopy is an invasive procedure. Some people struggle to cope with it and require intravenous sedation and/or analgesia. It is also resource-intensive, needing to be performed in specialist endoscopy units by a trained team. Across the UK, the demand for colonoscopy is outstripping capacity and the diagnosis of colorectal disease is being delayed. A colon capsule endoscope (CCE) is an alternative colorectal diagnostic. It is a ‘camera in a pill’ that can be swallowed and which passes through the gastrointestinal tract, obtaining visual images on the colon. There is now established experience of CCE in the UK. CCE might provide a less invasive method to diagnose colorectal disease if found to be accurate and effective and provide a means by which to increase the NHS diagnostic capacity.

The aim of this study is to determine the diagnostic accuracy of CCE when compared with colonoscopy in representative and clinically meaningful cohorts of patients. An evaluation of the experiences of CCE for the patient and clinical team and an assessment of cost effectiveness will be undertaken.

In workstream 1 (WS1), we shall perform a paired (back-to-back) study. Each participant will swallow the CCE and later the same day will have a colonoscopy. 973 participants will be recruited over 30 sites across the UK from three representative clinical contexts; suspected CRC, suspected IBD colitis and postpolypectomy surveillance. A nested substudy of intraobserver and interobserver agreement will be performed. WS2 will develop models of cost-effectiveness and WS3 will evaluate the patient and clinician experience, with reference to acceptability and choice.