Implementation of Optical Diagnosis of Diminutive Colorectal Polyps: DISCARD3 Study (Incorporating AI-DETECT)
- Conditions
- Colonic Polyp
- Interventions
- Diagnostic Test: CAD polyp-detection system
- Registration Number
- NCT04710693
- Lead Sponsor
- London North West Healthcare NHS Trust
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 614
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CAD polyp-detection system CAD polyp-detection system In this arm, a CAD polyp detection system will be used during the colonoscopy.
- Primary Outcome Measures
Name Time Method 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.
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.
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.
- Secondary Outcome Measures
Name Time Method 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.
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.
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.
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.
Trial Locations
- Locations (1)
St Mark's Hospital
🇬🇧Harrow, United Kingdom