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Resect and Discard Extension to FICE of NIcE Classification (FICE;NICE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2014 by Michele Tedeschi, Istituto Clinico Humanitas.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02263144
First Posted: October 13, 2014
Last Update Posted: October 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Universitaire Ziekenhuizen Leuven
Royal Alexandra Hospital
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Nuovo Regina Margherita Hospital
University of Erlangen-Nürnberg Medical School
University Hospital Regensburg
Hôpital Edouard Herriot
Information provided by (Responsible Party):
Michele Tedeschi, Istituto Clinico Humanitas
  Purpose
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.

Condition Intervention
Hyperplastic Polyps Adenomatous Polyps Procedure: virtual chromo-endoscopy using FICE Fujifilm Technology

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Resect and Discard Extension to Fuji Intelligent Color Enhancement (FICE) of Narrow Band Imaging International Colorectal Endoscopic (NicE) Classification

Resource links provided by NLM:


Further study details as provided by Michele Tedeschi, Istituto Clinico Humanitas:

Primary Outcome Measures:
  • 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. [ Time Frame: up to 6 months ]
    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.

  • Inter-observer agreement among the 7 experts [ Time Frame: up to 6 months ]
    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 .


Other Outcome Measures:
  • Accuracy of additional criteria, such as the presence of mucus, to differentiate between sub-types of non-neoplastic lesions (i.e. serrated lesions) [ Time Frame: up to 6 month ]

Biospecimen Retention:   Samples Without DNA
colonic polyps

Estimated Enrollment: 110
Study Start Date: May 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
histologically-verified <10mm polyps
histologically-verified <10mm polyps, analyzed by virtual chromo-endoscopy using FICE Fujifilm Technology
Procedure: virtual chromo-endoscopy using FICE Fujifilm Technology
For each polyps, any observer will use virtual chromo-endoscopy with FICE Fujifilm Technology

Detailed Description:
  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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Consecutive adult patients who were referred for elective outpatient colonoscopy
Criteria

Inclusion Criteria:

  1. The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic work-up;
  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:

  1. Patients with inflammatory bowel disease;
  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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02263144


Contacts
Contact: Alessandro Repici, MD +39282247493 alessandro.repici@humanitas.it

Locations
Belgium
Dept of Gastroenterology and Endoscopy, University Hospital Recruiting
Leuven, Belgium
Contact: Raf Bisschops, MD       raf.bisschops@med.kuleuven.be   
Principal Investigator: Raf Bisschops, MD         
France
Dept of Gastroenterology, Edouard Herriot Hospital, Hospices Civils of Lyon Recruiting
Lyon, France
Contact: Thierry Ponchon, MD       thierry.ponchon@chu-lyon.fr   
Principal Investigator: Thierry Ponchon, MD         
Germany
Department of Medicine I, University of Erlangen-Nürnberg Medical School Recruiting
Erlangen, Germany
Contact: Helmut Neumann, MD       helmut.neumann@uk-erlangen.de   
Principal Investigator: Helmut Neumann, MD         
Dept of Gastroenterology and interventional Endoscopy, Krankenhaus Barmherzige Brüder Recruiting
Regensburg, Germany
Contact: Oliver Pech, MD       oliver.pech@t-online.de   
Principal Investigator: Oliver Pech, MD         
Italy
Endoscopy Unit, Humanitas Research Hospital Recruiting
Rozzano, Milano, Italy, 20089
Contact: Alessandro Repici, MD    +39282247493    alessandro.repici@humanitas.it   
Principal Investigator: Alessandro Repici, MD         
Sub-Investigator: Camilla Ciscato, MD         
Digestive Endoscopy Unit, Nuovo Regina Margherita Hospital Recruiting
Rome, Italy
Contact: Cesare Hassan, MD       cesareh@hotmail.com   
Principal Investigator: Cesare Hassan, MD         
United Kingdom
Solent Centre for Digestive Diseases , Royal Alexandra Hospital Recruiting
Portsmouth, United Kingdom
Contact: Pradeep Bhandari, MD       pradeep.bhandari@porthosp.nhs.uk   
Principal Investigator: Pradeep Bhandari, MD         
Sponsors and Collaborators
Istituto Clinico Humanitas
Universitaire Ziekenhuizen Leuven
Royal Alexandra Hospital
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Nuovo Regina Margherita Hospital
University of Erlangen-Nürnberg Medical School
University Hospital Regensburg
Hôpital Edouard Herriot
Investigators
Principal Investigator: Alessandro Repici, MD Istituto Clinico Humanitas
  More Information

Publications:
Responsible Party: Michele Tedeschi, Responsabile Progetto Ricerca Clinica, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT02263144     History of Changes
Other Study ID Numbers: REDEFINE
First Submitted: September 25, 2014
First Posted: October 13, 2014
Last Update Posted: October 13, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Polyps
Adenomatous Polyps
Hyperplasia
Pathological Conditions, Anatomical
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pathologic Processes