Clinical trial NCT02263144: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyperplastic Polyps
Adenomatous Polyps
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
name: Royal Alexandra Hospital
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Nuovo Regina Margherita Hospital
name: University of Erlangen-Nürnberg Medical School
name: University Hospital Regensburg
name: Hôpital Edouard Herriot
First posted: 2014-10-13
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive adult patients who were referred for elective outpatient colonoscopy

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.

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.

Primary outcomes:
measure: 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.
timeFrame: up to 6 months
measure: Inter-observer agreement among the 7 experts
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
measure: Accuracy of additional criteria, such as the presence of mucus, to differentiate between sub-types of non-neoplastic lesions (i.e. serrated lesions)
timeFrame: up to 6 month
Locations:
city: Leuven
country: Belgium
facility: Dept of Gastroenterology and Endoscopy, University Hospital
city: Lyon
country: France
facility: Dept of Gastroenterology, Edouard Herriot Hospital, Hospices Civils of Lyon
city: Erlangen
country: Germany
facility: Department of Medicine I, University of Erlangen-Nürnberg Medical School
city: Regensburg
country: Germany
facility: Dept of Gastroenterology and interventional Endoscopy, Krankenhaus Barmherzige Brüder
city: Rozzano
country: Italy
facility: Endoscopy Unit, Humanitas Research Hospital
state: Milano
city: Rome
country: Italy
facility: Digestive Endoscopy Unit, Nuovo Regina Margherita Hospital
city: Portsmouth
country: United Kingdom
facility: Solent Centre for Digestive Diseases , Royal Alexandra Hospital
Study officials:
affiliation: Istituto Clinico Humanitas
name: Alessandro Repici, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.