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.
Study Type
OBSERVATIONAL
Enrollment
110
For each polyps, any observer will use virtual chromo-endoscopy with FICE Fujifilm Technology
Dept of Gastroenterology and Endoscopy, University Hospital
Leuven, Belgium
RECRUITINGDept of Gastroenterology, Edouard Herriot Hospital, Hospices Civils of Lyon
Lyon, France
RECRUITINGDepartment of Medicine I, University of Erlangen-Nürnberg Medical School
accuracy of the NICE criteria using FICE technology for differentiating between the non-neoplastic and neoplastic histotypes in diagnoses with high-confidence on a video-library of 110 polyps reviewed by 7 experts.
7 experts will review videos from a video-library of subcentimetric polyps removed and histologically verified and will assess each of the three NICE criteria (colour/vascularization/surface), and classify the lesion as neoplastic or non-neoplastic with low or high confidence.
Time frame: up to 6 months
Inter-observer agreement among the 7 experts
The inter-observer agreement, among the 7 experts, on the final diagnosis (neoplastic or non-neoplastic) and on each individual NICE criterion for each polyp will be determined by using K statistics .
Time frame: up to 6 months
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Erlangen, Germany
Dept of Gastroenterology and interventional Endoscopy, Krankenhaus Barmherzige Brüder
Regensburg, Germany
RECRUITINGEndoscopy Unit, Humanitas Research Hospital
Rozzano, Milano, Italy
RECRUITINGDigestive Endoscopy Unit, Nuovo Regina Margherita Hospital
Rome, Italy
RECRUITINGSolent Centre for Digestive Diseases , Royal Alexandra Hospital
Portsmouth, United Kingdom
RECRUITING