Colonic Polyp
Conditions
Brief summary
This is a prospective feasibility study. The aim of this work is to assess the acceptability and feasibility of optical diagnosis-led care in bowel cancer screening patients undergoing colonoscopy. This study will determine whether bowel cancer screening colonoscopists are able to consistently record and diagnose diminutive adenomas suitable for a resect and discard strategy allowing assignment of surveillance intervals according to Preservation and Incorporation of Valuable Endoscopic Innovations (PIVI) criteria. A practical quality assurance program around optical diagnosis will be introduced. The use of a CAD polyp-detection system will also be evaluated (AI-DETECT).
Interventions
DIAGNOSTIC_TESTCAD polyp-detection system
Software will be used during the procedure to aid the detection of polyps during the procedure.
Sponsors
London North West Healthcare NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Colonoscopy lists will be randomised for the use of a CAD polyp-detection system to be used as an adjunct to optical diagnosis. 50% of colonoscopy lists will be randomly assigned to use the CAD system and 50% of colonoscopy lists will not use the CAD system.
Eligibility
Sex/Gender
ALL
Age
55 Years to 74 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients aged 60-74 * with +ve Faecal Occult Blood/Faecal Immunochemical test attending for screening colonoscopy within BCSP (Bowel Cancer Screening Programme) * with an established history of adenomas attending for surveillance colonoscopy within BCSP * Patients aged 55 - referred for screening colonoscopy following positive Bowel Scope Screening flexible sigmoidoscopy
Exclusion criteria
* Patients with a risk profile (due to family history or other) whose follow-up will be outside standard BCSP * Patients with inflammatory bowel disease * Unable to consent * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Polyp detection rate (AI-DETECT) | 2 weeks for each participant | The investigators will assess the impact on polyp detection rate when using a CAD polyp-detection system. |
| Learning curve to achieve accurate optical diagnosis | Through study completion, approximately 18-24 months | The investigators will assess endoscopist learning curve by calculating percentage of accurate optical diagnoses of diminutive polyps (when compared with histopathology) for all endoscopists over the course of the study. |
| Proportion of cases where optical diagnosis derived surveillance intervals concur with histopathology derived surveillance intervals | 2 weeks for each participant | For each participant, the surveillance interval according to international guidelines (UK, US, European) will be determined based on optical diagnoses alone and then separately based on histopathology results alone. The proportion of cases where both optical diagnosis derived and histopathology derived surveillance intervals agree will be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of optical diagnosis | 2 weeks for each participant | The sensitivity of optical diagnosis will be assessed for polyps identified during the course of the study. |
| Serrated polyp detection rate (AI-DETECT) | 2 weeks for each participant | The investigators will assess the impact on serrated polyp detection rate when using a CAD polyp-detection system. |
| Specificity of optical diagnosis | 2 weeks for each participant | The specificity of optical diagnosis will be assessed for polyps identified during the course of the study. |
| Adenoma detection rate (AI-DETECT) | 2 weeks for each participant | The investigators will assess the impact on adenoma detection rate when using a CAD polyp-detection system. |
Countries
United Kingdom
Outcome results
None listed