CAD EYE Detection of Remaining Lesions After EMR

Not Applicable

Recruiting

• Conditions: Colorectal Dysplasia; Colorectal Neoplasms

• Registration Number: NCT05542030
• Lead Sponsor: Instituto Ecuatoriano de Enfermedades Digestivas

Brief Summary

In the last decade, many innovative systems have been developed to support and improve the diagnosis accuracy during endoscopic studies. CAD-Eye™ (Fujifilm, Tokyo, Japan) is a computer-assisted diagnostic (CADx) system that uses artificial intelligence for the detection and characterization of polyps during colonoscopy. However, the accuracy of CAD-Eye™ in the recognition of remaining lesions after endoscopic mucosal resection (EMR) has not been broadly evaluated.

Finally, based on the importance of complete resection of the colonic mucosal lesions, namely suspicious high-grade dysplasia or early invasive cancer, the investigators aimed to assess the accuracy of CAD-Eye™ in the detection of remaining lesions after the procedure.

Detailed Description

Nowadays, the increased polyp and adenoma detection rate, and its early treatment have reduced considerably colorectal cancer-related mortality. For lesions suspicious of high-grade dysplasia or early invasive cancer, the endoscopic mucosal resection (EMR), along with snare polypectomy, is now considered one of the established standard treatments. However, there are many ´difficult-to-treat lesions´ such as the large and fibrotic ones, which can lead to incomplete resections.

Based on the above, many newly diagnostic techniques guided by artificial intelligence (AI), currently proposed to improve the polyp detection rate during colonoscopy, can be applied for the detection of remaining lesions after endoscopic treatment.

CAD-Eye™ is CADx for polyp detection and characterization. It improves polyp visualization by using techniques such as blue-laser imaging (BLI-LASER), blue-light imaging (BLI-LED), and linked-color imaging (LCI). This device aimed to improve real-time polyp detection, helping experts identify multiple polyps simultaneously and common inadvertently missed lesions (flat lesions, polyps in difficult areas).

CAD-Eye™ had demonstrated in previous studies an accuracy of 89% to 91.7% in polyp detection. However, few studies had demonstrated its performance in the detection of remaining lesions after EMR. The investigators aimed to take advantage of this system in the detection of remaining lesions immediately after EMR and in its endoscopic control after three months.

Study Timeline

• Study First Submitted: 2022-09-05
• Study Start: 2022-09-12
• Study First Submitted QC: 2022-09-13
• Study First Posted: 2022-09-15
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28
• Primary Completion: 2024-03-01
• Study Completion: 2024-09-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients referred to our center with an indication of colonoscopy and EMR for the treatment of lesions suspicious of high-grade dysplasia and early invasive cancer.
• Patients who authorize EMR and colonoscopy.
• Signed informed consent

Exclusion Criteria

• Any clinical condition which makes EMR inviable.
• Poor bowel preparation score defined as the total Boston bowel preparation score (BBPS) <6 and the right-segment score <2
• Patients with more than one previous EMR
• Lost on a three-month follow-up after EMR
• Pregnancy or nursing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Lesions recurrence after EMR	up to 1 week	Detection of remaining lesions immediately after EMR procedure based on endoscopist expertise (EMR without CAD-Eye™ group) or CAD-Eye™ (EMR + CAD-Eye™ group). Lesions will be confirmed by biopsy.; Data will be summarized as frequencies.
Lesions recurrence in a three-month follow-up after EMR	up to 3 months	Evaluation of CAD-Eye™ in the detection of recurrent lesions after EMR procedure. Remaining lesions detected by CAD-Eye™ in the three-month follow-up. Lesions will be confirmed by biopsy.; Data will be summarized as frequencies.

Secondary Outcome Measures

Name	Time	Method
Recurrence risk after EMR	up to 1 week	Calculate de recurrence risk by the Sydney EMR recurrence tool (SERT) in a scale from 0 to 4; * 2 points: size of 40 mm or larger; * 1 point: Intraprocedural bleeding (IPB); * 1 point: high-grade dysplasia (HGD) in histopathology

Trial Locations

Locations (1)

Carlos Robles-Medranda; 🇪🇨 Guayaquil, Guayas, Ecuador