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

NCT ID: NCT04710693

Last Updated: 2021-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

614 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-14

Study Completion Date

2021-12-03

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).

Detailed Description

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Conditions

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Colonic Polyp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CAD polyp-detection system

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

Group Type OTHER

CAD polyp-detection system

Intervention Type DIAGNOSTIC_TEST

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

Standard (no CAD polyp-detection system)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CAD polyp-detection system

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

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

55 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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London North West Healthcare NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St Mark's Hospital

Harrow, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 35724693 (View on PubMed)

Other Identifiers

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245862

Identifier Type: -

Identifier Source: org_study_id