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Completed

NCT Number: NCT04710693

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

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).

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Key information

Conditions

Colonic Polyp Colonic Polyps Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

55 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Mark's Hospital

Harrow, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CAD polyp-detection system

Diagnostic Test

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

Primary outcomes

  1. Learning curve to achieve accurate optical diagnosis

    Time frame: Through study completion, approximately 18-24 months

    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.

  2. Proportion of cases where optical diagnosis derived surveillance intervals concur with histopathology derived surveillance intervals

    Time frame: 2 weeks for each participant

    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.

  3. Polyp detection rate (AI-DETECT)

    Time frame: 2 weeks for each participant

    The investigators will assess the impact on polyp detection rate when using a CAD polyp-detection system.

Secondary outcomes

  1. Sensitivity of optical diagnosis

    Time frame: 2 weeks for each participant

    The sensitivity of optical diagnosis will be assessed for polyps identified during the course of the study.

  2. Specificity of optical diagnosis

    Time frame: 2 weeks for each participant

    The specificity of optical diagnosis will be assessed for polyps identified during the course of the study.

  3. Adenoma detection rate (AI-DETECT)

    Time frame: 2 weeks for each participant

    The investigators will assess the impact on adenoma detection rate when using a CAD polyp-detection system.

  4. Serrated polyp detection rate (AI-DETECT)

    Time frame: 2 weeks for each participant

    The investigators will assess the impact on serrated polyp detection rate when using a CAD polyp-detection system.

Sponsors and collaborators

Lead sponsor

London North West Healthcare NHS Trust

Other

Registry information

Official study title

Implementation of Optical Diagnosis of Diminutive Colorectal Polyps in Real Life Clinical Practice: DISCARD3 Study (Incorporating AI-DETECT)

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 15, 2021
Registry last updated
Dec 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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