Improving Optical Diagnosis of Colorectal Polyps Using CADx and BASIC.

Colorectal Cancer Clinical Trial

Official title:

Improving Optical Diagnosis of Colorectal Polyps Using Computer-aided Diagnosis (CADx) and the BLI Adenoma Serrated International Classification (BASIC).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04349787
• Other study ID #: METC 2019-1231
• Status: Completed
• Start date: November 26, 2019
• Est. completion date: March 8, 2020

Study information

• Verified date: April 2020
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 8, 2020
• Est. primary completion date: March 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Polyp
• Polyps

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (3)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Catharina Ziekenhuis Eindhoven, Eindhoven University of Technology

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

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. Review. — View Citation

Byrne MF, Chapados N, Soudan F, Oertel C, Linares Pérez 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of CADx versus endoscopists	The diagnostic accuracy of characterizing colorectal polyps (into benign versus (pre-)malignant) made by CADx in comparison to the diagnostic accuracy of both expert endoscopists and novices. In which histology is the gold standard.	6 months
Secondary	Diagnostic accuracy of BASIC versus intuition	The diagnostic accuracy of both expert endoscopists and novices in characterizing colorectal polyps (into hyperplastic polyp, adenoma, sessile serrated adenoma, or adenocarcinoma) based on the clinical classification model BASIC, in comparison to the diagnostic accuracy based on intuition. In which histology is the gold standard.	6 months
Secondary	Diagnostic metrics of CADx	The sensitivity, specificity, negative and positive predictive value of characterizing colorectal polyps (into benign versus (pre-)malignant) made by CADx.	6 months
Secondary	AUC of CADx	Area Under ROC Curve (AUC) of CADx for characterizing colorectal polyps (into benign versus (pre-)malignant) made by CADx.	6 months
Secondary	Diagnostic metrics of endoscopists	The sensitivity, specificity, negative and positive predictive value of characterizing colorectal polyps (into hyperplastic polyp, adenoma, sessile serrated adenoma, or adenocarcinoma) of both expert endoscopists and novices.	6 months
Secondary	Diagnostic metrics of endoscopists for high confidence diagnosis	The diagnostic accuracy, sensitivity, specificity, negative and positive predictive value of both expert endoscopists and novices for optical diagnosis made with high (>90%) confidence.	6 months
Secondary	Interobserver agreement	The interobserver agreement of experts, novices and CADx for characterizing colorectal polyps.	6 months
Secondary	Computation time of CADx	The computation time per image of CADx for characterizing colorectal polyps.	6 months