Validation of the NICE Classification Using Pentax Chromoendoscopy

CompletedOBSERVATIONAL
Enrollment

95

Participants

Timeline

Start Date

April 1, 2017

Primary Completion Date

May 1, 2018

Study Completion Date

July 1, 2018

Conditions
Colorectal Polyp
Interventions
DEVICE

Pentax chromoendoscopy (i-scan and Optical Enhancement)

All lesions will be evaluated using the 3 i-scan modes and the 2 OE modes without magnification. The lesion size data, location and macroscopic shape of the lesions based on the Paris classification will be recorded. Finally all lesions will be classified in real-time into 3 types based on NICE classification (NICE 1, hyperplastic polyps; NICE 2, adenoma and superficial submucosal carcinoma; NICE 3, SM-d invasive carcinoma). A level of confidence (high or low) will be assign in each stage. Polyp's images will be photographically and videotape recorded. All polyps will be resected or biopsied for histopathological examination used as the criterion standard for the analysis.

Trial Locations (1)

090505

Ecuadorian Institute of Digestive Diseases, Omnihospital, Guayaquil

All Listed Sponsors
lead

Instituto Ecuatoriano de Enfermedades Digestivas

OTHER

NCT03155308 - Validation of the NICE Classification Using Pentax Chromoendoscopy | Biotech Hunter | Biotech Hunter