Resect and Discard Extension to FICE of NIcE Classification

• Conditions: Hyperplastic Polyps; Adenomatous Polyps
• Interventions: Procedure: virtual chromo-endoscopy using FICE Fujifilm Technology

• Registration Number: NCT02263144
• Lead Sponsor: Istituto Clinico Humanitas

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 Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-09-25
• Status Verified: 2014-10
• Study First Submitted QC: 2014-10-08
• Last Update Submitted: 2014-10-08
• Study First Posted: 2014-10-13
• Last Update Posted: 2014-10-13
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
histologically-verified <10mm polyps	virtual chromo-endoscopy using FICE Fujifilm Technology	histologically-verified \<10mm polyps, analyzed by virtual chromo-endoscopy using FICE Fujifilm Technology

Primary Outcome Measures

Name	Time	Method
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.	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	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 .

Trial Locations

Locations (7)

Dept of Gastroenterology and Endoscopy, University Hospital; 🇧🇪 Leuven, Belgium

Department of Medicine I, University of Erlangen-Nürnberg Medical School; 🇩🇪 Erlangen, Germany

Dept of Gastroenterology, Edouard Herriot Hospital, Hospices Civils of Lyon; 🇫🇷 Lyon, France

Dept of Gastroenterology and interventional Endoscopy, Krankenhaus Barmherzige Brüder; 🇩🇪 Regensburg, Germany

Endoscopy Unit, Humanitas Research Hospital; 🇮🇹 Rozzano, Milano, Italy

Digestive Endoscopy Unit, Nuovo Regina Margherita Hospital; 🇮🇹 Rome, Italy

Solent Centre for Digestive Diseases , Royal Alexandra Hospital; 🇬🇧 Portsmouth, United Kingdom