An interventional study of EMR with CAD-Eye™ and EMR without CAD-Eye™ in Colorectal Dysplasia and Colorectal Neoplasms, sponsored by Instituto Ecuatoriano de Enfermedades Digestivas. Recruiting at 1 site in Ecuador. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by Instituto Ecuatoriano de Enfermedades Digestivas · Not applicable, Interventional, and Diagnostic
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.
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.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 60 is below the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Instituto Ecuatoriano de Enfermedades Digestivas is the lead sponsor of 39 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group constitutes patients with lesions suggestive of high-grade dysplasia or early invasive cancer approached with endoscopic mucosal resection, subjected to colonoscopy + CAD-Eye™ system evaluation for the detection of remaining malignant tissue. For this group, the investigators used as a complement tool an AI system (CAD-Eye™) for the detection of remaining lesions immediately after EMR and in a three-month follow-up.
Diagnostic Test: EMR with CAD-Eye™ · Diagnostic Test: Follow-up colonoscopy with CAD-Eye™
This group constitutes patients with lesions suggestive of high-grade dysplasia or early invasive cancer approached with endoscopic mucosal resection and subjected to colonoscopy. The detection of remaining lesions immediately after EMR is based on the visual impression of the expert. For this group, the investigators used as a complement tool an AI system (CAD-Eye™) only for the evaluation of the post-procedure scar to detect remaining lesions in the three-month follow-up.
Diagnostic Test: EMR without CAD-Eye™ · Diagnostic Test: Follow-up colonoscopy with CAD-Eye™
Patients of group 1 undergoing Intervention 1 are subjected to an EMR with CAD-Eye™ to detect the remaining lesions immediately after the endoscopic procedure. The suspected remaining lesions in the post-procedure defect detected with CAD-Eye™ are removed and sent to pathology to confirm the diagnosis.
Patients of group 2, undergoing intervention 2, subjected to an EMR alone. The immediate detection of remaining lesions is based on the visual impression of the expert. The suspected remaining lesions in the post-procedure defect are removed and sent to pathology to confirm the diagnosis.
Patients undergoing Interventions 1 and 2, with a previous EMR, are assigned for a three-month follow-up using the CAD-Eye™ as a complementary procedure to detect remaining lesions. For the detection of residual lesions, the colonoscope with the CAD-Eye™ assistance is used during the post-procedural scar evaluation. Suspicious lesions detected are removed and sent to pathology for final diagnosis.
Lesions recurrence after EMR
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.
Time frame: up to 1 week
Lesions recurrence in a three-month follow-up after EMR
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.
Time frame: up to 3 months
Recurrence risk after EMR
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
Time frame: up to 1 week
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Instituto Ecuatoriano de Enfermedades Digestivas