Loading clinical trials...
Loading clinical trials...
Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion in Colon Lesions. Prospective Multicenter Study in Routine Clinical Practice
The purpose of this study is to evaluate the diagnostic accuracy of NICE classification to predict deep submucosal invasion of colonic polyps \> 1 cm, considering histology as the gold standard, in a group of endoscopists who previously performed a training program.
In the first phase of the study, a learning program of NICE classification based on examples will be performed. Forty images will be evaluated before and after the learning program. In the second phase of the study, all consecutive patients who underwent to a colonoscopy will be included if a lesion greater than 1 cm is found and the endoscopy is performed with a high definition colonoscope with Narrow Band Imaging (NBI). Patients, lesions and endoscopy equipment characteristics will be recorded. Subsequently, histological diagnosis of the lesion will also be recorded. Evaluated test (NICE classification) was blinded to the pathologist who performed the gold standard test (histology). In case of adenocarcinomas, histological predictors of lymph node metastases, with predefined assessment criteria, will also be recorded. Finally, histological preparations of adenocarcinomas will be sent to the reference center and two experienced pathologists will examine them again.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Ignasi Puig
Manresa, Barcelona, Spain
Start Date
July 1, 2014
Primary Completion Date
July 1, 2016
Completion Date
July 1, 2016
Last Updated
June 27, 2018
2,171
ACTUAL participants
NBI used by trained endoscopists
DEVICE
Lead Sponsor
Asociación Española de Gastroenterología
NCT07089615
NCT02196649
NCT02198729
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions