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

Colonic Polyp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04710693
• Other study ID #: 245862
• Status: Completed
• Phase: N/A
• Start date: February 14, 2020
• Est. completion date: December 3, 2021

Study information

• Verified date: September 2021
• Source: London North West Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 614
• Est. completion date: December 3, 2021
• Est. primary completion date: December 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps
• Polyps

Intervention

Diagnostic Test:
• CAD polyp-detection system
Software will be used during the procedure to aid the detection of polyps during the procedure.

Locations

Country	Name	City	State
United Kingdom	St Mark's Hospital	Harrow

Sponsors (1)

Lead Sponsor	Collaborator
London North West Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Sensitivity of optical diagnosis	The sensitivity of optical diagnosis will be assessed for polyps identified during the course of the study.	2 weeks for each participant
Secondary	Specificity of optical diagnosis	The specificity of optical diagnosis will be assessed for polyps identified during the course of the study.	2 weeks for each participant
Secondary	Adenoma detection rate (AI-DETECT)	The investigators will assess the impact on adenoma detection rate when using a CAD polyp-detection system.	2 weeks for each participant
Secondary	Serrated polyp detection rate (AI-DETECT)	The investigators will assess the impact on serrated polyp detection rate when using a CAD polyp-detection system.	2 weeks for each participant