Adenomatous Polyps Clinical Trial
Official title:
Resect and Discard Extension to Fuji Intelligent Color Enhancement (FICE) of Narrow Band Imaging International Colorectal Endoscopic (NicE) Classification
The purpose of this prospective, non-interventional study is to validate the Narrow Band Imaging International Colorectal Endoscopic (NICE) classification for differentiating subcentimetric hyperplastic and adenomatous polyps by using Fuji Intelligent Color Enhancement (FICE) technology with high-definition without optical magnification.
1. In order to create a video-library of endoscopic cases, patients undergoing screening
or diagnostic colonoscopy will be considered for inclusion. Patients with at least one
histologically verified <10 mm polyp will be included. A short video-clip (around 15-20
seconds) of each polyp both at white-light and FICE-light will be recorded and stored
in an anonymized database.
2. Once the video-library is completed, each of 7 experts will independently review all
the cases. For each case, any observer will assess each of the three NICE criteria
(colour/vascularization/surface), the degree of confidence (low/high), and classify the
lesion as neoplastic or non-neoplastic. The primary outcomes are the accuracy of FICE
technology with high-definition and without magnification, when adopting NICE
classification, to differentiate between hyperplastic and adenomatous lesions, and the
inter-observer agreement in such differentiation. Secondary end-points are to assess at
multivariate measure the role of any individual criteria of NICE classification in the
discrimination between the two histotypes, and possible adaptations of NICE
classification in order to be applied with FICE.
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Observational Model: Case-Only, Time Perspective: Prospective
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