Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion

NCT02328066 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2171

Last updated 2018-06-27

No results posted yet for this study

Summary

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.

Conditions

  • Colonic Polyps

Interventions

DEVICE

NBI used by trained endoscopists

Examination of colon lesions, using NBI and NICE classification, by endoscopists who previously performed an easy learning program. The learning program consists on the reading of two reference articles and a tutorial explaining the NICE classification. This tutorial shows several lesions and describes the characteristic features in which the classifications focus on.

Sponsors & Collaborators

  • Asociación Española de Gastroenterología

    lead OTHER

Principal Investigators

  • Pablo Vega · Complexo Hospitalario de Ourense

  • Maria Luisa de Castro · Complexo Hospitalario Universitario de Vigo-CHUVI

  • Eva Martínez-Bauer · Corporacion Parc Tauli

  • Angel Fernández · Hospital Clínico de Zaragoza

  • Gema de la Poza · Hospital de Fuenlabrada

  • Jorge López · Hospital de Móstoles

  • Oscar Nogales · Gregorio Marañón Hospital

  • Beatriz Peñas · Hospital Universitario Ramon y Cajal

  • Pilar Díez · Hospital Río Ortega

  • Marta Hernández · Hospital Universitario Puerta de Hierro

  • Antonio Zebenzuy · Hospital Universitario de Canarias

  • Aurora Burgos · Hospital Universitario La Paz

  • Jorge Mendoza · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

  • Marco Antonio Álvarez · Hospital del Mar

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02328066 on ClinicalTrials.gov