Clinical trial NCT04710693: Implementation of Optical Diagnosis of Diminutive Colorectal Polyps: DISCARD3 Study (Incorporating AI-DETECT)
Official title: Implementation of Optical Diagnosis of Diminutive Colorectal Polyps in Real Life Clinical Practice: DISCARD3 Study (Incorporating AI-DETECT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Polyp
Lead sponsor: London North West Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 614
Sex: ALL
Minimum age (years): 55
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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).


Eligibility criteria: 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

Primary outcomes:
measure: Learning curve to achieve accurate optical diagnosis
timeFrame: Through study completion, approximately 18-24 months
measure: Proportion of cases where optical diagnosis derived surveillance intervals concur with histopathology derived surveillance intervals
timeFrame: 2 weeks for each participant
measure: Polyp detection rate (AI-DETECT)
timeFrame: 2 weeks for each participant
Secondary outcomes:
measure: Sensitivity of optical diagnosis
timeFrame: 2 weeks for each participant
measure: Specificity of optical diagnosis
timeFrame: 2 weeks for each participant
measure: Adenoma detection rate (AI-DETECT)
timeFrame: 2 weeks for each participant
measure: Serrated polyp detection rate (AI-DETECT)
timeFrame: 2 weeks for each participant
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: St Mark's Hospital
Study officials:
References:
citation: 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.