CAD EYE Detection of Remaining Lesions After EMR
Accuracy of CAD Eye in the Detection of Colonic Remaining Lesions After Endoscopic Mucosal Resection: a Pilot Study
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2022
CompletedStudy Start
First participant enrolled
September 12, 2022
CompletedFirst Posted
Study publicly available on registry
September 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 12, 2024
CompletedSeptember 28, 2023
September 1, 2023
1.5 years
September 5, 2022
September 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
up to 3 months
Secondary Outcomes (1)
Recurrence risk after EMR
up to 1 week
Study Arms (2)
Endoscopic mucosal resection + CAD-Eye™
EXPERIMENTALThis 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.
Endoscopic mucosal resection without CAD Eye
ACTIVE COMPARATORThis 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Carlos Robles-Medranda
Guayaquil, Guayas, 090505, Ecuador
Related Publications (6)
Kliegis L, Obst W, Bruns J, Weigt J. Can a Polyp Detection and Characterization System Predict Complete Resection? Dig Dis. 2022;40(1):115-118. doi: 10.1159/000516974. Epub 2021 May 6.
PMID: 33940578BACKGROUNDYoshida N, Inoue K, Tomita Y, Kobayashi R, Hashimoto H, Sugino S, Hirose R, Dohi O, Yasuda H, Morinaga Y, Inada Y, Murakami T, Zhu X, Itoh Y. An analysis about the function of a new artificial intelligence, CAD EYE with the lesion recognition and diagnosis for colorectal polyps in clinical practice. Int J Colorectal Dis. 2021 Oct;36(10):2237-2245. doi: 10.1007/s00384-021-04006-5. Epub 2021 Aug 18.
PMID: 34406437BACKGROUNDDumoulin FL, Hildenbrand R. Endoscopic resection techniques for colorectal neoplasia: Current developments. World J Gastroenterol. 2019 Jan 21;25(3):300-307. doi: 10.3748/wjg.v25.i3.300.
PMID: 30686899BACKGROUNDNeumann H, Kreft A, Sivanathan V, Rahman F, Galle PR. Evaluation of novel LCI CAD EYE system for real time detection of colon polyps. PLoS One. 2021 Aug 26;16(8):e0255955. doi: 10.1371/journal.pone.0255955. eCollection 2021.
PMID: 34437563BACKGROUNDMin M, Deng P, Zhang W, Sun X, Liu Y, Nong B. Comparison of linked color imaging and white-light colonoscopy for detection of colorectal polyps: a multicenter, randomized, crossover trial. Gastrointest Endosc. 2017 Oct;86(4):724-730. doi: 10.1016/j.gie.2017.02.035. Epub 2017 Mar 9.
PMID: 28286095BACKGROUNDTate DJ, Desomer L, Klein A, Brown G, Hourigan LF, Lee EY, Moss A, Ormonde D, Raftopoulos S, Singh R, Williams SJ, Zanati S, Byth K, Bourke MJ. Adenoma recurrence after piecemeal colonic EMR is predictable: the Sydney EMR recurrence tool. Gastrointest Endosc. 2017 Mar;85(3):647-656.e6. doi: 10.1016/j.gie.2016.11.027. Epub 2016 Nov 28.
PMID: 27908600BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos Robles-Medranda, MD FASGE
Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Endoscopy Division
Study Record Dates
First Submitted
September 5, 2022
First Posted
September 15, 2022
Study Start
September 12, 2022
Primary Completion
March 1, 2024
Study Completion
September 12, 2024
Last Updated
September 28, 2023
Record last verified: 2023-09