Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAD polyp-detection system | Other | In this arm, a CAD polyp detection system will be used during the colonoscopy. |
|
| Standard (no CAD polyp-detection system) | No Intervention | In this arm, a CAD polyp detection system will not be used during the colonoscopy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAD polyp-detection system | Diagnostic Test | Software will be used during the procedure to aid the detection of polyps during the procedure. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Patients aged 60-74
Patients aged 55 - referred for screening colonoscopy following positive Bowel Scope Screening flexible sigmoidoscopy
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Mark's Hospital | Harrow | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35724693 | Derived | Ahmad A, Moorghen M, Wilson A, Stasinos I, Haycock A, Humphries A, Monahan K, Suzuki N, Thomas-Gibson S, Vance M, Thiruvilangam K, Dhillon A, Saunders BP. Implementation of optical diagnosis with a "resect and discard" strategy in clinical practice: DISCARD3 study. Gastrointest Endosc. 2022 Dec;96(6):1021-1032.e2. doi: 10.1016/j.gie.2022.06.019. Epub 2022 Jun 18. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
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 |