Artificial Intelligence for Diminutive Polyp Characterization

Not Applicable

Recruiting

• Conditions: Colorectal Neoplasms
• Interventions: Device: GI-Genius artificial intelligence

• Registration Number: NCT05391477
• Lead Sponsor: Hospital Universitario La Fe

Brief Summary

Artificial intelligence is a promising tool that may have a role in characterizing colon epithelial lesions (CADx), helping to get a reliable optical diagnosis regardless of the endoscopist experience. Performances of the different CADx systems are variable but it seems that, in most cases, high accuracy and sensitivities are achieved. However, these CADx systems have been developed and validated using still pictures or videos, and a real-world accurate test is lacking. No clinical trials have tested this technology in clinical practice and, therefore, performance in real colonoscopies, practical problems, applicability, and cost are unknown.

Detailed Description

The resect-and-discard (R\&D) and diagnose-and-leave (D\&L) strategies have been proposed as a means to reduce costs in the evaluation of colorectal polyps avoiding a substantial number of pathology evaluations. A pre-requisite for this paradigm shift is an accurate optical diagnosis (HOD). However, performance results for HOD have been highly variable among endoscopists representing a barrier for the adoption of the R\&D and the D\&L strategies.

Artificial intelligence is a promising tool that may have a role in characterizing colon epithelial lesions (CADx), helping to get a reliable optical diagnosis regardless of the endoscopist experience. Performances of the different CADx systems are variable but it seems that, in most cases, high accuracy and sensitivities are achieved. However, these CADx systems have been developed and validated using still pictures or videos, and a real-world accurate test is lacking. No clinical trials have tested this technology in clinical practice and, therefore, performance in real colonoscopies, practical problems, applicability, and cost are unknown.

Methods and analysis: The ODDITY trial is a European multicenter randomized, parallel-group superiority trial comparing GI-Genius artificial intelligence optical diagnosis (AIOD) to human optical diagnosis (HOD) of colon lesions ≤ 5 mm performed by endoscopists, using histopathology as the gold standard. A total of 643 patients attending a colonoscopy within a CRC screening program (either FIT- or colonoscopy-based) or because of post-polypectomy surveillance will be randomized to the ADI group or the HOD (control) group. A computer-generated 1:1 blocking randomization scheme stratified for center and endoscopist will be used.

Study Timeline

• Study First Submitted: 2022-04-05
• Study First Submitted QC: 2022-05-24
• Study First Posted: 2022-05-26
• Study Start: 2023-02-27
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-30
• Last Update Posted: 2023-05-31
• Primary Completion: 2024-05
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 643

Inclusion Criteria

• Patients attending a colonoscopy within a population-based CRC screening program (FIT- or colonoscopy-based) or because of post-polypectomy surveillance,
• Written informed consent before the colonoscopy,

Exclusion Criteria

• None, patient included
• Previous history of inflammatory bowel disease.
• Previous history of CRC
• Previous CR resection
• Polyposis or hereditary CRC syndrome
• Coagulopathy/Anticoagulants
• Unwillingness to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Artificial intelligence optical diagnosis (AIOD):	GI-Genius artificial intelligence	GI-Genius will provide an artificial intelligence diagnosis (AIOD) for every lesion detected (adenoma vs non-adenoma). Only diminutive lesions will be considered for the analysis of the main outcome. However, data on larger lesions will be recorded to describe GI-Genius´ performance in detail (secondary outcome). The time to get an AIOD will be recorded. An in situ surveillance interval will be provided if possible

Primary Outcome Measures

Name	Time	Method
Comparison of the AIOD and HOD accuracy of the post-polypectomy surveillance interval assignment with respect to the surveillance interval assigned by pathology	At the end of the study (2 years)	A surveillance interval will be assigned using optical diagnosis of ≤ 5 mm polyps (Arm 1: AIOD; Arm 2: HOD of polyps diagnosed with high confidence) plus histopathology of \> 5 mm polyps and polyps ≤ 5 mm diagnosed with low confidence. For each patient included, the optical-diagnosis surveillance assignment will be matched with the histology-directed one, and a concordance rate will be calculated. The post-polypectomy surveillance interval will be calculated using the ESGE 2020 and the USMSTF 2020 guidelines. Per-patient analysis.
Comparison of the AIOD and HOD negative predictive value (NPV) for adenoma in rectosigmoid polyps ≤ 5 mm with respect to histology	At the end of the study (2 years)	The optical diagnosis of ≤ 5 mm rectosigmoid polyps (Arm 1: AIOD; Arm 2: HOD, only high-confidence diagnosis) reliability on ruling out the presence of an adenoma will be calculated using histopathology as the gold standard. Per-lesion analysis. NPV = number of confirmed hyperplastic polyps/number of hyperplastic optical diagnosis

Secondary Outcome Measures

Name	Time	Method
Comparison of the AIOD and HOD diagnostic accuracy parameters of polyps ≤ 5 mm (Arm 1: AIOD; Arm 2: HOD) with respect to histology	Interim analysis (when half of the sample size had been included). At the end of the study (2 years)	Operative characteristics (sensitivity, specificity, positive and negative predictive value and positive likely hood ratio) using histopathology as the gold standard. Per-lesion analysis
Cost-effectiveness of AIOD	At the end of the study (2 years)	The economic burden of applying the AIOD and HOD to assign the post-polypectomy surveillance intervals compared to the histology-driven strategy. A direct cost evaluation will be performed including medical and non-medical costs. Per-patient analysis.
Comparison of the proportion of adverse events in colonoscopies with and without the AIOD device.	30 days after the colonoscopy (Day 30)	The occurrence and severity of adverse events in colonoscopies with and without the AIOD device will be monitored during the 30-days period after the procedure. Adverse events are defined as: abdominal pain or discomfort, post-polypectomy bleeding, perforation, post-polypectomy syndrome and infection. Per-patient analysis
Proportion of patients accepting to have their polyps diagnosed by the AI system or human optical diagnosis (designed questionnaire)	Day of colonoscopy (Day 1)	The proportion of patients willing to have their polyps diagnosed by an AI system or HOD will be assessed using a structured questionnaire. Per-patient analysis.

Trial Locations

Locations (1)

Hospital Universitari i Politècnic La Fe; 🇪🇸 Valencia, Spain