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

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ClinicalTrials.gov Identifier: NCT02263144
Recruitment Status : Unknown
Verified October 2014 by Michele Tedeschi, Istituto Clinico Humanitas.
Recruitment status was:  Recruiting
First Posted : October 13, 2014
Last Update Posted : October 13, 2014
Sponsor:
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

Tracking Information
First Submitted Date September 25, 2014
First Posted Date October 13, 2014
Last Update Posted Date October 13, 2014
Study Start Date May 2014
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 8, 2014)
  • 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 .
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: October 8, 2014)
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 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Resect and Discard Extension to FICE of NIcE Classification
Official Title Resect and Discard Extension to Fuji Intelligent Color Enhancement (FICE) of Narrow Band Imaging International Colorectal Endoscopic (NicE) Classification
Brief Summary 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.
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
colonic polyps
Sampling Method Non-Probability Sample
Study Population Consecutive adult patients who were referred for elective outpatient colonoscopy
Condition
  • Hyperplastic Polyps
  • Adenomatous Polyps
Intervention Procedure: virtual chromo-endoscopy using FICE Fujifilm Technology
For each polyps, any observer will use virtual chromo-endoscopy with FICE Fujifilm Technology
Study Groups/Cohorts histologically-verified <10mm polyps
histologically-verified <10mm polyps, analyzed by virtual chromo-endoscopy using FICE Fujifilm Technology
Intervention: Procedure: virtual chromo-endoscopy using FICE Fujifilm Technology
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 8, 2014)
110
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2014
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium,   France,   Germany,   Italy,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02263144
Other Study ID Numbers REDEFINE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Michele Tedeschi, Istituto Clinico Humanitas
Study Sponsor Istituto Clinico Humanitas
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
Investigators
Principal Investigator: Alessandro Repici, MD Istituto Clinico Humanitas
PRS Account Istituto Clinico Humanitas
Verification Date October 2014