CAD EYE Detection of Remaining Lesions After EMR

September 26, 2023 updated by: Carlos Robles-Medranda, Instituto Ecuatoriano de Enfermedades Digestivas

Accuracy of CAD Eye in the Detection of Colonic Remaining Lesions After Endoscopic Mucosal Resection: a Pilot Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Ecuador
    • Guayas
      • Guayaquil, Guayas, Ecuador, 090505
        • Recruiting
        • Carlos Robles-Medranda
        • Sub-Investigator:
          • Martha Arevalo-Mora, MD
        • Contact:
        • Sub-Investigator:
          • Juan Alcivar-Vasquez, MD
        • Sub-Investigator:
          • Maria Egas-Izquierdo, MD
        • Sub-Investigator:
          • Miguel Puga-Tejada, MD
        • Sub-Investigator:
          • Jorge Baquerizo-Burgos, MD
        • Sub-Investigator:
          • Domenica Cunto, MD
        • Sub-Investigator:
          • Hannah P. Lukashok, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endoscopic mucosal resection + CAD-Eye™

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™

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.

Diagnostic test: Follow-up colonoscopy with CAD-Eye™

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.
Active Comparator: Endoscopic mucosal resection without 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: Follow-up colonoscopy with CAD-Eye™

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.

Diagnostic test: EMR without CAD-Eye™

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lesions recurrence after EMR
Time Frame: 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.
up to 1 week
Lesions recurrence in a three-month follow-up after EMR
Time Frame: 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.
up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence risk after EMR
Time Frame: 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
up to 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Ecuatoriano de Enfermedades Digestivas

Investigators

  • Principal Investigator: Carlos Robles-Medranda, MD FASGE, Instituto Ecuatoriano de Enfermedades Digestivas (IECED)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2022

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

September 12, 2024

Study Registration Dates

First Submitted

September 5, 2022

First Submitted That Met QC Criteria

September 13, 2022

First Posted (Actual)

September 15, 2022

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IECED-08202022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colorectal Neoplasms

Clinical Trials on EMR with CAD-Eye™

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe