Real-life Implementation of an AI-based Optical Diagnosis — AI-OD  

Artificial Intelligence Clinical Trial

Official title: Real-life Implementation of an Artificial Intelligence Based Optical Diagnosis Strategy for Diminutive Colorectal Polyps

Status Recruiting

Clinical Trial Summary

This is a prospective study that is the first to implement resect and discard and diagnose and leave strategies in real-time practice using stringent documentation and adjudication by 2 expert endoscopists as the gold standard. Therefore, this study mainly aims to evaluate the agreement between (CADx) assisted optical diagnosis and adjudication by two expert endoscopists in establishing surveillance intervals concordant with the European Society for Gastrointestinal Endoscopy (ESGE) and US Multisociety task force (USMSTF) guidelines.

Clinical Trial Description

All patients who meet the in/exclusion criteria can be enrolled.

Eligible patients will be informed about the study through a consent form that includes information on optical diagnosis (resect and discard, diagnose and leave) and AI/CADx systems. Subsequently, patients will be asked if they are willing to participate in the study, using AI-assisted optical diagnosis and the "resect and discard" and "diagnose and leave" strategy. If a patient declines to undergo optical diagnosis, they will be asked about the reason for their refusal to participate in the study. The options for their response include:

1. Concerns regarding undergoing an optical diagnosis.

2. Reluctance to participate in research projects in general.

3. Other reasons.

4. Preference not to answer the question. This data along with patient characteristics (age, sex) will be captured and kept to analyse reasons for non-participation. Patients who agree to participate in the study will undergo standard colonoscopy procedures with AI-assisted optical diagnosis for all diminutive colorectal polyps identified. High-definition colonoscopes with a joint computer-assisted classification (CADx) support (CAD-EYE software EW10-EC02) will be used. The endoscopists will also use the CAD-EYE blue light imaging (BLI) mode to enhance the visualization of polyp features. During the optical diagnosis using CADx, the most probable diagnosis (neoplastic or hyperplastic) will be displayed on the endoscopy screen. If the serrated pathology subtype is determined as the most probable histology, the endoscopists will make the final decision. They will also indicate whether their optical diagnosis was made with low or high confidence. When high-risk histology features are observed using BLI, the endoscopists will inform the research assistant for documentation, and the polyp will be sent for pathology examination in accordance with the ASGE PIVI guidelines recommendations. All polyps >5mm will be send for pathology evaluation as per standard of care. Polyp size will be measured using virtual scale technology integrated in the computer-assisted system (CAD) to ensure an accurate polyp sizing.

The surveillance intervals will be determined according to the most recent USMSTF and ESGE guidelines. Two independent endoscopists blinded to the initial optical diagnosis will review all video recordings and will independently perform the AI-assisted optical diagnosis for each 1-5mm polyp. For polyps >5mm, diagnosis will be evaluated through histology as per standard of care. ;

Related Conditions & MeSH terms

• Artificial Intelligence
• Disease

• NCT number: NCT06059378
• Study type: Interventional
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Completion date: January 30, 2024