Improving Optical Diagnosis of Colorectal Polyps Using CADx and BASIC.
NCT ID: NCT04349787
Last Updated: 2020-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2019-11-26
2020-03-08
Brief Summary
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Second, this study evaluates the effect of using a clinical classification model Blue Light Imaging Adenoma Serrated International (BASIC) on the diagnostic accuracy of the optical diagnosis of colorectal polyps compared to intuitive optical diagnosis for both expert endoscopists and novices.
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Detailed Description
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This observational study developes a computer-aided diagnosis (CADx) system to differentiate between benign and (pre-)malignant CRPs, using state-of-the-art machine learning methods and deep learning architectures. For the development, HDWL and BLI images are used. The CADx is trained using histology as gold standard. The CADx is externally validated using on a set of 60 colorectal polyps. This study will evaluate if the optical diagnosis of colorectal polyps can be improved with the aid of CADx.
In addition, both expert endoscopists and novices optically diagnose the colorectal polyps. In the first, pre-training phase, endoscopists optically diagnose colorectal polyps based on intuition. Afterwards, in the post-training phase, the same set of colorectal polyps is optically diagnosed based on a clinical classification system; BLI Adenoma Serrated International Classification (BASIC). This study will evaluate if the optical diagnosis of colorectal polyps can be improved with the aid of BASIC in both expert and non-expert hands.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Colorectal polyp patients
Patients who have a colonoscopy in regular care as part of the Dutch colorectal screening program, in the context of complaints or in the context of the follow-up of previously diagnosed bowel diseases. And who have at least one colorectal polyp found and resected during the examination.
Computer-aided diagnosis (CADx)
Optical diagnosis of colorectal polyps made with computer-aided diagnosis (CADx) using state-of-the-art machine learning methods and deep learning architectures.
BLI Adenoma Serrated International Classification (BASIC)
Optical diagnosis of colorectal polyps made with BLI Adenoma Serrated International Classification (BASIC), both by exert endoscopists and novices.
Interventions
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Computer-aided diagnosis (CADx)
Optical diagnosis of colorectal polyps made with computer-aided diagnosis (CADx) using state-of-the-art machine learning methods and deep learning architectures.
BLI Adenoma Serrated International Classification (BASIC)
Optical diagnosis of colorectal polyps made with BLI Adenoma Serrated International Classification (BASIC), both by exert endoscopists and novices.
Eligibility Criteria
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Inclusion Criteria
* Availability of at least one high definition white light image and one Blue Light Imaging (BLI) image of the colorectal polyp;
* Overall high quality of the colorectal polyp image;
* Availability of the histological results of the colorectal polyp;
* Minimal age of 18 years old.
Exclusion Criteria
* Endoscopic instruments visible at the colorectal polyp image;
* More than one polyp visible at the colorectal polyp image.
18 Years
ALL
No
Sponsors
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Catharina Ziekenhuis Eindhoven
OTHER
Eindhoven University of Technology
OTHER
Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Ad Masclee, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Maastricht Universitair Medisch Centrum
Locations
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Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Countries
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References
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ASGE Technology Committee; Abu Dayyeh BK, Thosani N, Konda V, Wallace MB, Rex DK, Chauhan SS, Hwang JH, Komanduri S, Manfredi M, Maple JT, Murad FM, Siddiqui UD, Banerjee S. ASGE Technology Committee systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting real-time endoscopic assessment of the histology of diminutive colorectal polyps. Gastrointest Endosc. 2015 Mar;81(3):502.e1-502.e16. doi: 10.1016/j.gie.2014.12.022. Epub 2015 Jan 16.
Subramaniam S, Hayee B, Aepli P, Schoon E, Stefanovic M, Kandiah K, Thayalasekaran S, Alkandari A, Bassett P, Coron E, Pech O, Hassan C, Neumann H, Bisschops R, Repici A, Bhandari P. Optical diagnosis of colorectal polyps with Blue Light Imaging using a new international classification. United European Gastroenterol J. 2019 Mar;7(2):316-325. doi: 10.1177/2050640618822402. Epub 2019 Jan 6.
Byrne MF, Chapados N, Soudan F, Oertel C, Linares Perez M, Kelly R, Iqbal N, Chandelier F, Rex DK. Real-time differentiation of adenomatous and hyperplastic diminutive colorectal polyps during analysis of unaltered videos of standard colonoscopy using a deep learning model. Gut. 2019 Jan;68(1):94-100. doi: 10.1136/gutjnl-2017-314547. Epub 2017 Oct 24.
van der Zander QEW, Schreuder RM, Fonolla R, Scheeve T, van der Sommen F, Winkens B, Aepli P, Hayee B, Pischel AB, Stefanovic M, Subramaniam S, Bhandari P, de With PHN, Masclee AAM, Schoon EJ. Optical diagnosis of colorectal polyp images using a newly developed computer-aided diagnosis system (CADx) compared with intuitive optical diagnosis. Endoscopy. 2021 Dec;53(12):1219-1226. doi: 10.1055/a-1343-1597. Epub 2021 Mar 10.
Other Identifiers
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METC 2019-1231
Identifier Type: -
Identifier Source: org_study_id
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