Improving Optical Diagnosis of Colorectal Polyps Using CADx and BASIC.

NCT ID: NCT04349787

Last Updated: 2020-04-16

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-26

Study Completion Date

2020-03-08

Brief Summary

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Primary, this study aims to develop and validate a computer-aided diagnosis (CADx) system for the characterization of colorectal polyps.

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.

Detailed Description

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Optical diagnosis of colorectal polyps, the in-vivo characterization of the histology by endoscopists, is of increasing interest for clinical endoscopy practice. Recent studies have shown that thresholds for optical diagnosis are met in highly selected groups of expert endoscopists, but the same is not true in community endoscopy practices. In order to improve optical diagnosis, imaging enhancement techniques and the use of artificial intelligence are proposed.

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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Colorectal Cancer Colorectal Polyp

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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)

Intervention Type OTHER

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)

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with at least one colorectal polyp found and resected during colonoscopy in regular care;
* 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

* Objection to participate in medical scientific research, reported in the medical file;
* Endoscopic instruments visible at the colorectal polyp image;
* More than one polyp visible at the colorectal polyp image.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role collaborator

Eindhoven University of Technology

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Netherlands

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.

Reference Type BACKGROUND
PMID: 25597420 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31080616 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29066576 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33368056 (View on PubMed)

Other Identifiers

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METC 2019-1231

Identifier Type: -

Identifier Source: org_study_id

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