Implementation of Optical Diagnosis of Diminutive Colorectal Polyps: DISCARD3 Study (Incorporating AI-DETECT)

Study Overview
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Brief Summary
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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).

Official Title
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Implementation of Optical Diagnosis of Diminutive Colorectal Polyps in Real Life Clinical Practice: DISCARD3 Study (Incorporating AI-DETECT)

Conditions
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Colonic Polyp

Intervention / Treatment
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* Diagnostic Test: CAD polyp-detection system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CAD polyp-detection system<br>In this arm, a CAD polyp detection system will be used during the colonoscopy. | Diagnostic Test: CAD polyp-detection system<br>* Software will be used during the procedure to aid the detection of polyps during the procedure.<br>|
| No Intervention: Standard (no CAD polyp-detection system)<br>In this arm, a CAD polyp detection system will not be used during the colonoscopy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Learning curve to achieve accurate optical diagnosis | 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. | Through study completion, approximately 18-24 months | 
| Proportion of cases where optical diagnosis derived surveillance intervals concur with histopathology derived surveillance intervals | 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. | 2 weeks for each participant | 
| Polyp detection rate (AI-DETECT) | The investigators will assess the impact on polyp detection rate when using a CAD polyp-detection system. | 2 weeks for each participant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of optical diagnosis | The sensitivity of optical diagnosis will be assessed for polyps identified during the course of the study. | 2 weeks for each participant | 
| Specificity of optical diagnosis | The specificity of optical diagnosis will be assessed for polyps identified during the course of the study. | 2 weeks for each participant | 
| Adenoma detection rate (AI-DETECT) | The investigators will assess the impact on adenoma detection rate when using a CAD polyp-detection system. | 2 weeks for each participant | 
| Serrated polyp detection rate (AI-DETECT) | The investigators will assess the impact on serrated polyp detection rate when using a CAD polyp-detection system. | 2 weeks for each participant |