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

Istituto Clinico Humanitas

Status

Unknown

Conditions

Adenomatous Polyps

Hyperplastic Polyps

Treatments

Procedure: virtual chromo-endoscopy using FICE Fujifilm Technology

Study type

Observational

Funder types

Other

Identifiers

NCT02263144

REDEFINE

Details and patient eligibility

About

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.

Full description

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.
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.

Enrollment

110 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.