Resect and Discard Extension to FICE of NIcE Classification

Adenomatous Polyps Clinical Trial

— FICE;NICE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02263144
• Other study ID #: REDEFINE
• Status: Recruiting
• Phase: N/A
• First received: September 25, 2014
• Last updated: October 8, 2014
• Start date: May 2014
• Est. completion date: December 2014

Study information

• Verified date: October 2014
• Source: Istituto Clinico Humanitas
• Contact: Alessandro Repici, MD
• Phone: +39282247493
• Email: alessandro.repici[@]humanitas.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adenomatous Polyps
• Hyperplasia
• Hyperplastic Polyps
• Polyps

Intervention

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

Locations

Country	Name	City	State
Belgium	Dept of Gastroenterology and Endoscopy, University Hospital	Leuven
France	Dept of Gastroenterology, Edouard Herriot Hospital, Hospices Civils of Lyon	Lyon
Germany	Department of Medicine I, University of Erlangen-Nürnberg Medical School	Erlangen
Germany	Dept of Gastroenterology and interventional Endoscopy, Krankenhaus Barmherzige Brüder	Regensburg
Italy	Digestive Endoscopy Unit, Nuovo Regina Margherita Hospital	Rome
Italy	Endoscopy Unit, Humanitas Research Hospital	Rozzano	Milano
United Kingdom	Solent Centre for Digestive Diseases , Royal Alexandra Hospital	Portsmouth

Sponsors (8)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Hôpital Edouard Herriot, Nuovo Regina Margherita Hospital, Royal Alexandra Hospital, Universitaire Ziekenhuizen Leuven, University Hospital Regensburg, University of Erlangen-Nürnberg Medical School

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  United Kingdom, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Primary	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	No