Real-time Diagnosis of Diminutive Colorectal Polyps Using AI

NCT ID: NCT05349110

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 105 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-20
• Study Completion Date: 2022-12-31

Brief Summary

Correct endoscopic prediction of the histopathology and differentiation between benign, pre-malignant, and malignant colorectal polyps (optical diagnosis) remains difficult. Artificial intelligence has great potential in image analysis in gastrointestinal endoscopy. Aim of this study is to investigate the real-time diagnostic performance of AI4CRP for the classification of diminutive colorectal polyps, and to compare it with the real-time diagnostic performance of commercially available CADx systems.

Detailed Description

Correct endoscopic prediction of the histopathology and differentiation between benign, pre-malignant, and malignant colorectal polyps (optical diagnosis) remains difficult. Despite additional training, even experienced endoscopists continue to fail meeting international thresholds set for safe implementation of treatment strategies based on optical diagnosis.

Multiple machine learning techniques - computer-aided diagnosis (CADx) systems - have been developed for applications in medical imaging within colonoscopy and can improve endoscopic classification of colorectal polyps.

Aim of this study is to explore the feasibility of the workflow using AI4CRP (a CNN based CADx system) real-time in the endoscopy suite, and to investigate the real-time diagnostic performance of AI4CRP for the diagnosis of diminutive (<5mm) colorectal polyps. Secondary, the real-time performance of commercially available CADx systems will be investigated and compared with AI4CRP performance.

Conditions

Colorectal Neoplasms; Colorectal Polyp

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Gastroenterology patients

Patient receiving a colonoscopy because of regular care will be considered eligible for inclusion if at least one diminutive colorectal polyp is encountered during the colonoscopy. Patients receive an endoscopic procedure in the context of the Dutch national screening program, because of gastrointestinal symptoms, or because of follow-up of previously diagnosed bowel diseases.

Colonoscopies will be executed using Fujifilm endoscopy systems (Fujifilm® Corporation, Tokyo, Japan), using Pentax endoscopy systems (Pentax Medical®, Hamburg, Germany), and using Olympus endoscopy systems (Olympus®, Tokyo, Japan).

Computer-aided diagnosis (CADx) systems

Intervention Type: DEVICE

• AI4CRP (artificial intelligence for colorectal polyps), a CNN based computer-aided diagnosis system for diagnosis of colorectal polyps (COMET-OPTICAL research group);
• CAD EYE, a computer-aided diagnosis system for diagnosis of colorectal polyps (Fujifilm® Corporation, Tokyo, Japan).

Interventions

Computer-aided diagnosis (CADx) systems

• AI4CRP (artificial intelligence for colorectal polyps), a CNN based computer-aided diagnosis system for diagnosis of colorectal polyps (COMET-OPTICAL research group);
• CAD EYE, a computer-aided diagnosis system for diagnosis of colorectal polyps (Fujifilm® Corporation, Tokyo, Japan).

Intervention Type: DEVICE

Other Intervention Names

AI4CRP, artificial intelligence for colorectal polyps (COMET-OPTICAL research group); CAD EYE (Fujifilm® Corporation, Tokyo, Japan)

Eligibility Criteria

Inclusion Criteria

• Age >18 years;
• Patients with at least one colorectal polyps encountered during colonoscopy;
• Patients referred for a colonoscopy by the Dutch bowel cancer screening program, patients undergoing a colonoscopy for endoscopic surveillance, or patients undergoing a colonoscopy because of complaints;
• Written informed consent.

Exclusion Criteria

• Patients with prior history of inflammatory bowel diseases (IBD) or polyposis syndromes;
• Patients with inadequate bowel preparations after adequate washing, suctioning, and cleaning manoeuvres have been performed by the endoscopist;
• Patients undergoing an emergency colonoscopy;
• Written objection in the patient file for participation in scientific research.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role: collaborator

Eindhoven University of Technology

OTHER

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erik Schoon, Prof Dr MD

Role: PRINCIPAL_INVESTIGATOR

Maastricht Universitair Medisch Centrum

Locations

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Site Status: RECRUITING

Catharina Ziekenhuis Eindhoven

Eindhoven, North Brabant, Netherlands

Site Status: COMPLETED

Countries

Netherlands

Central Contacts

Quirine van der Zander, Drs MD

Role: CONTACT

q.vanderzander@maastrichtuniversity.nl

031433882241

Erik Schoon, Prof Dr MD

Role: CONTACT

erik.schoon@catharinaziekenhuis.nl

031433882241

Facility Contacts

Quirine van der Zander, Drs MD

Role: primary

q.vanderzander@maastrichtuniversity.nl

031433882241

Erik Schoon, Prof Dr MD

Role: backup

erik.schoon@catharinaziekenhuis.nl

031433882241

Other Identifiers

METC2021-3036

Identifier Type: -

Identifier Source: org_study_id