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

NCT04710693 | Completed

• 1 other identifier: 245862
• Study Type: interventional
• Target: 614
• Locations: 1 country
• Sites: 1

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).

Conditions

Colonic Polyp

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Sensitivity of optical diagnosis

  2 weeks for each participant

• Specificity of optical diagnosis

  2 weeks for each participant

• Adenoma detection rate (AI-DETECT)

  2 weeks for each participant

• Serrated polyp detection rate (AI-DETECT)

  2 weeks for each participant

Study Arms (2)

CAD polyp-detection system

OTHER

In this arm, a CAD polyp detection system will be used during the colonoscopy.

Diagnostic Test: CAD polyp-detection system

Standard (no CAD polyp-detection system)

NO INTERVENTION

In this arm, a CAD polyp detection system will not be used during the colonoscopy.

Interventions

CAD polyp-detection system DIAGNOSTIC_TEST

Software will be used during the procedure to aid the detection of polyps during the procedure.

CAD polyp-detection system

Eligibility Criteria

• Age: 55 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London North West Healthcare NHS Trust: lead

Study Sites (1)

St Mark's Hospital

Harrow, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35724693 DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: January 15, 2021
• Study Start: February 14, 2020
• Primary Completion: December 3, 2021
• Study Completion: December 3, 2021
• Last Updated: December 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)