NCT05542030|Unknown
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
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Accuracy of CAD Eye in the Detection of Colonic Remaining Lesions After Endoscopic Mucosal Resection: a Pilot Study
Sponsor study identifier
interventional
60
1 country
1
Study Start
September 12, 2022
Actual (reported)Primary Completion
March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 12, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 12, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 5, 2022
Actual (reported)September 12, 2022
Actual (reported)September 15, 2022
Actual (reported)March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 12, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Recurrence risk after EMR
up to 1 week
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.
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.
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.
Carlos Robles-Medranda
Guayaquil, Guayas, 090505, Ecuador
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.
Yoshida 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.
Carlos Robles-Medranda, MD FASGE
Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
First Submitted
September 5, 2022
First Posted
September 15, 2022
Study Start
September 12, 2022
Actual (reported)Primary Completion
Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for Colorectal Laterally Spreading Lesions.
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.
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Dumoulin 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.
Neumann 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.
Min 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.
Tate 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.
March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 12, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 28, 2023
Record last verified: 2023-09
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