Resect and Discard Extension to FICE of NIcE Classification
NCT ID: NCT02263144
Last Updated: 2014-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
110 participants
OBSERVATIONAL
2014-05-31
2014-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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histologically-verified <10mm polyps
histologically-verified \<10mm polyps, analyzed by virtual chromo-endoscopy using FICE Fujifilm Technology
virtual chromo-endoscopy using FICE Fujifilm Technology
For each polyps, any observer will use virtual chromo-endoscopy with FICE Fujifilm Technology
Interventions
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virtual chromo-endoscopy using FICE Fujifilm Technology
For each polyps, any observer will use virtual chromo-endoscopy with FICE Fujifilm Technology
Eligibility Criteria
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Inclusion Criteria
2. The patient is at satisfactory risk to undergo abdominal surgery;
3. The patient must understand and provide written consent for the procedure.
Exclusion Criteria
2. Patients with a personal history of polyposis syndrome;
3. Patients with diverticulitis or toxic megacolon;
4. Patients with a history of radiation therapy to abdomen or pelvis.
5. Patients with a history of severe cardiovascular, pulmonary, liver or renal disease;
6. Personal history of coagulation disorders or use of anticoagulants
7. Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
ALL
Yes
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Royal Alexandra Hospital
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Nuovo Regina Margherita Hospital
OTHER
University of Erlangen-Nürnberg Medical School
OTHER
University Hospital Regensburg
OTHER
Hôpital Edouard Herriot
OTHER
Istituto Clinico Humanitas
OTHER
Responsible Party
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Michele Tedeschi
Responsabile Progetto Ricerca Clinica
Principal Investigators
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Alessandro Repici, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto Clinico Humanitas
Locations
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Dept of Gastroenterology and Endoscopy, University Hospital
Leuven, , Belgium
Dept of Gastroenterology, Edouard Herriot Hospital, Hospices Civils of Lyon
Lyon, , France
Department of Medicine I, University of Erlangen-Nürnberg Medical School
Erlangen, , Germany
Dept of Gastroenterology and interventional Endoscopy, Krankenhaus Barmherzige Brüder
Regensburg, , Germany
Endoscopy Unit, Humanitas Research Hospital
Rozzano, Milano, Italy
Digestive Endoscopy Unit, Nuovo Regina Margherita Hospital
Rome, , Italy
Solent Centre for Digestive Diseases , Royal Alexandra Hospital
Portsmouth, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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REDEFINE
Identifier Type: -
Identifier Source: org_study_id
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