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

L

London North West Healthcare NHS Trust

Status

Completed

Conditions

Colonic Polyp

Treatments

Diagnostic Test: CAD polyp-detection system

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Enrollment

614 patients

Sex

All

Ages

55 to 74 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

614 participants in 2 patient groups

CAD polyp-detection system
Other group
Description:
In this arm, a CAD polyp detection system will be used during the colonoscopy.
Treatment:
Diagnostic Test: CAD polyp-detection system
Standard (no CAD polyp-detection system)
No Intervention group
Description:
In this arm, a CAD polyp detection system will not be used during the colonoscopy.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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