NCT04349787

Improving Optical Diagnosis of Colorectal Polyps Using CADx and BASIC.

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Colorectal Cancer
• Colorectal Polyp

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2019-11-26
• Primary completion: 2020-03-08
• Completion: 2020-03-08
• First posted: 2020-04-16
• Last updated: 2020-04-16

Locations

1 site across 1 country: Netherlands