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

Primary Purpose

Colonic Polyp

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
CAD polyp-detection system
Sponsored by
London North West Healthcare NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonic Polyp

Eligibility Criteria

55 Years - 74 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • St Mark's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

CAD polyp-detection system

Standard (no CAD polyp-detection system)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
Polyp detection rate (AI-DETECT)
The investigators will assess the impact on polyp detection rate when using a CAD polyp-detection system.

Secondary Outcome Measures

Sensitivity of optical diagnosis
The sensitivity of optical diagnosis will be assessed for polyps identified during the course of the study.
Specificity of optical diagnosis
The specificity of optical diagnosis will be assessed for polyps identified during the course of the study.
Adenoma detection rate (AI-DETECT)
The investigators will assess the impact on adenoma detection rate when using a CAD polyp-detection system.
Serrated polyp detection rate (AI-DETECT)
The investigators will assess the impact on serrated polyp detection rate when using a CAD polyp-detection system.

Full Information

First Posted
December 14, 2020
Last Updated
December 21, 2021
Sponsor
London North West Healthcare NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04710693
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 14, 2020 (Actual)
Primary Completion Date
December 3, 2021 (Actual)
Study Completion Date
December 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London North West Healthcare NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyp

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
614 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CAD polyp-detection system
Arm Type
Other
Arm Description
In this arm, a CAD polyp detection system will be used during the colonoscopy.
Arm Title
Standard (no CAD polyp-detection system)
Arm Type
No Intervention
Arm Description
In this arm, a CAD polyp detection system will not be used during the colonoscopy.
Intervention Type
Diagnostic Test
Intervention Name(s)
CAD polyp-detection system
Intervention Description
Software will be used during the procedure to aid the detection of polyps during the procedure.
Primary Outcome Measure Information:
Title
Learning curve to achieve accurate optical diagnosis
Description
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.
Time Frame
Through study completion, approximately 18-24 months
Title
Proportion of cases where optical diagnosis derived surveillance intervals concur with histopathology derived surveillance intervals
Description
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.
Time Frame
2 weeks for each participant
Title
Polyp detection rate (AI-DETECT)
Description
The investigators will assess the impact on polyp detection rate when using a CAD polyp-detection system.
Time Frame
2 weeks for each participant
Secondary Outcome Measure Information:
Title
Sensitivity of optical diagnosis
Description
The sensitivity of optical diagnosis will be assessed for polyps identified during the course of the study.
Time Frame
2 weeks for each participant
Title
Specificity of optical diagnosis
Description
The specificity of optical diagnosis will be assessed for polyps identified during the course of the study.
Time Frame
2 weeks for each participant
Title
Adenoma detection rate (AI-DETECT)
Description
The investigators will assess the impact on adenoma detection rate when using a CAD polyp-detection system.
Time Frame
2 weeks for each participant
Title
Serrated polyp detection rate (AI-DETECT)
Description
The investigators will assess the impact on serrated polyp detection rate when using a CAD polyp-detection system.
Time Frame
2 weeks for each participant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
St Mark's Hospital
City
Harrow
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35724693
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.
Results Reference
derived

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

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