Resect and Discard Extension to FICE of NIcE Classification

NCT02263144 | Unknown

• 1 other identifier: REDEFINE
• Study Type: observational
• Target: 110
• Locations: 5 countries
• Sites: 7

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.

Conditions

Hyperplastic Polyps; Adenomatous Polyps

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Study Arms (1)

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

Interventions

virtual chromo-endoscopy using FICE Fujifilm Technology PROCEDURE

For each polyps, any observer will use virtual chromo-endoscopy with FICE Fujifilm Technology

histologically-verified <10mm polyps

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive adult patients who were referred for elective outpatient colonoscopy

You may qualify if:

• The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic work-up;
• The patient is at satisfactory risk to undergo abdominal surgery;
• The patient must understand and provide written consent for the procedure.

You may not qualify if:

• Patients with inflammatory bowel disease;
• Patients with a personal history of polyposis syndrome;
• Patients with diverticulitis or toxic megacolon;
• Patients with a history of radiation therapy to abdomen or pelvis.
• Patients with a history of severe cardiovascular, pulmonary, liver or renal disease;
• Personal history of coagulation disorders or use of anticoagulants
• 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.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator
• Royal Alexandra Hospital: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• Nuovo Regina Margherita Hospital: collaborator
• University of Erlangen-Nürnberg Medical School: collaborator
• University Hospital Regensburg: collaborator
• Hôpital Edouard Herriot: collaborator

Study Sites (7)

Dept of Gastroenterology and Endoscopy, University Hospital

Leuven, Belgium

RECRUITING

Dept of Gastroenterology, Edouard Herriot Hospital, Hospices Civils of Lyon

Lyon, France

RECRUITING

Department of Medicine I, University of Erlangen-Nürnberg Medical School

Erlangen, Germany

RECRUITING

Dept of Gastroenterology and interventional Endoscopy, Krankenhaus Barmherzige Brüder

Regensburg, Germany

RECRUITING

Endoscopy Unit, Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

RECRUITING

Digestive Endoscopy Unit, Nuovo Regina Margherita Hospital

Rome, Italy

RECRUITING

Solent Centre for Digestive Diseases , Royal Alexandra Hospital

Portsmouth, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 22609383 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

colonic polyps

MeSH Terms

Conditions

Adenomatous Polyps

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Alessandro Repici, MD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Repici, MD

CONTACT

+39282247493; alessandro.repici@humanitas.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Responsabile Progetto Ricerca Clinica

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: October 13, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 13, 2014

Record last verified: 2014-10

Locations

FR (1); DE (2); IT (2); GB (1); BE (1)