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

Resect and Discard Extension to Fuji Intelligent Color Enhancement (FICE) of Narrow Band Imaging International Colorectal Endoscopic (NicE) Classification

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.

Study Overview

• Status: Unknown
• Conditions: Adenomatous Polyps; Hyperplastic Polyps
• Intervention / Treatment: Procedure: virtual chromo-endoscopy using 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.

• Study Type: Observational
• Enrollment (Anticipated): 110

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • Recruiting
    • Dept of Gastroenterology and Endoscopy, University Hospital
    • Contact: Raf Bisschops, MD; Email: raf.bisschops@med.kuleuven.be
    • Principal Investigator: Raf Bisschops, MD
• France
  • Lyon, France
    • Recruiting
    • Dept of Gastroenterology, Edouard Herriot Hospital, Hospices Civils of Lyon
    • Contact: Thierry Ponchon, MD; Email: thierry.ponchon@chu-lyon.fr
    • Principal Investigator: Thierry Ponchon, MD
• Germany
  • Erlangen, Germany
    • Recruiting
    • Department of Medicine I, University of Erlangen-Nürnberg Medical School
    • Contact: Helmut Neumann, MD; Email: helmut.neumann@uk-erlangen.de
    • Principal Investigator: Helmut Neumann, MD
  • Regensburg, Germany
    • Recruiting
    • Dept of Gastroenterology and interventional Endoscopy, Krankenhaus Barmherzige Brüder
    • Contact: Oliver Pech, MD; Email: oliver.pech@t-online.de
    • Principal Investigator: Oliver Pech, MD
• Italy
  • Rome, Italy
    • Recruiting
    • Digestive Endoscopy Unit, Nuovo Regina Margherita Hospital
    • Contact: Cesare Hassan, MD; Email: cesareh@hotmail.com
    • Principal Investigator: Cesare Hassan, MD
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Recruiting
      • Endoscopy Unit, Humanitas Research Hospital
      • Sub-Investigator: Camilla Ciscato, MD
• United Kingdom
  • Portsmouth, United Kingdom
    • Recruiting
    • Solent Centre for Digestive Diseases , Royal Alexandra Hospital
    • Contact: Pradeep Bhandari, MD; Email: pradeep.bhandari@porthosp.nhs.uk
    • Principal Investigator: Pradeep Bhandari, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive adult patients who were referred for elective outpatient colonoscopy

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas
• Collaborators: Universitaire Ziekenhuizen KU Leuven; University of Erlangen-Nürnberg Medical School; Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Hôpital Edouard Herriot; Royal Alexandra Hospital; University Hospital Regensburg; Nuovo Regina Margherita Hospital
• Investigators: Principal Investigator: Alessandro Repici, MD, Istituto Clinico Humanitas

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: September 25, 2014
• First Submitted That Met QC Criteria: October 8, 2014
• First Posted (Estimate): October 13, 2014

Study Record Updates

• Last Update Posted (Estimate): October 13, 2014
• Last Update Submitted That Met QC Criteria: October 8, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Pathological Conditions, Anatomical; Adenoma; Polyps; Adenomatous Polyps
• Other Study ID Numbers: REDEFINE