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| Name | Class |
|---|---|
| Universitaire Ziekenhuizen KU Leuven | OTHER |
| Royal Alexandra Hospital | OTHER |
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| histologically-verified <10mm polyps | histologically-verified <10mm polyps, analyzed by virtual chromo-endoscopy using FICE Fujifilm Technology |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| virtual chromo-endoscopy using FICE Fujifilm Technology | Procedure | For each polyps, any observer will use virtual chromo-endoscopy with FICE Fujifilm Technology |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 . | up to 6 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of additional criteria, such as the presence of mucus, to differentiate between sub-types of non-neoplastic lesions (i.e. serrated lesions) | up to 6 month |
Inclusion Criteria:
Exclusion Criteria:
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Consecutive adult patients who were referred for elective outpatient colonoscopy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessandro Repici, MD | Contact | +39282247493 | alessandro.repici@humanitas.it |
| Name | Affiliation | Role |
|---|---|---|
| Alessandro Repici, MD | Istituto Clinico Humanitas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Gastroenterology and Endoscopy, University Hospital | Recruiting | Leuven | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22609383 | Background | Hewett DG, Kaltenbach T, Sano Y, Tanaka S, Saunders BP, Ponchon T, Soetikno R, Rex DK. Validation of a simple classification system for endoscopic diagnosis of small colorectal polyps using narrow-band imaging. Gastroenterology. 2012 Sep;143(3):599-607.e1. doi: 10.1053/j.gastro.2012.05.006. Epub 2012 May 15. |
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| ID | Term |
|---|---|
| D018256 | Adenomatous Polyps |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Nuovo Regina Margherita Hospital |
| OTHER |
| University of Erlangen-Nürnberg Medical School | OTHER |
| University Hospital Regensburg | OTHER |
| Hôpital Edouard Herriot | OTHER |
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colonic polyps
| Dept of Gastroenterology, Edouard Herriot Hospital, Hospices Civils of Lyon | Recruiting | Lyon | France |
|
| Department of Medicine I, University of Erlangen-Nürnberg Medical School | Recruiting | Erlangen | Germany |
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| Dept of Gastroenterology and interventional Endoscopy, Krankenhaus Barmherzige Brüder | Recruiting | Regensburg | Germany |
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| Endoscopy Unit, Humanitas Research Hospital | Recruiting | Rozzano | Milano | 20089 | Italy |
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| Digestive Endoscopy Unit, Nuovo Regina Margherita Hospital | Recruiting | Rome | Italy |
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| Solent Centre for Digestive Diseases , Royal Alexandra Hospital | Recruiting | Portsmouth | United Kingdom |
|