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Search / Trial NCT02328066

Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion

Launched by ASOCIACIÓN ESPAÑOLA DE GASTROENTEROLOGÍA · Dec 26, 2014

Trial Information

Current as of June 09, 2025

Completed

Keywords

Nbi Nice Classification Deep Submucosal Invasion Colonic Polyps [C23.300.825.411.235] Colonoscopy [E01.370.372.250.250.200]

ClinConnect Summary

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 (NIC...

Gender

ALL

Eligibility criteria

  • Inclusion patients criteria:
  • Patients\> 18 years
  • Lesion Type 0 of Paris classification, greater than 1 cm, found in a colonoscopy performed by any medical indication with a high definition endoscope with Narrow Band Imaging.
  • Achievable histology by endoscopic or surgical resection.
  • Writing informed consent given.
  • Exclusion patients criteria:
  • Age \<18 years.
  • Refusal to give informed consent.
  • Contraindication for endoscopic or surgical resection.
  • Urgent colonoscopy indication (eg severe rectorrhagia.).
  • Patients with inflammatory bowel disease.
  • Suspected metastatic neoplasia by previous imaging tests.
  • Exclusion lesions criteria:
  • Polyp previously biopsied or resected.
  • Poor preparation that does not allow a proper assessment of the lesion.
  • NBI not performed.
  • Unavailable or indefinite histology (endoscopic or surgical resection).

About Asociación Española De Gastroenterología

The Asociación Española de Gastroenterología (AEG) is a leading professional organization dedicated to advancing the field of gastroenterology in Spain. Committed to promoting research, education, and clinical practice in digestive health, AEG plays a vital role in fostering collaboration among healthcare professionals, researchers, and institutions. Through its support of clinical trials and innovative studies, AEG aims to enhance patient care, develop new therapeutic strategies, and improve outcomes for individuals with gastrointestinal disorders. With a focus on scientific rigor and ethical standards, AEG is at the forefront of driving advancements in gastroenterological research and practice.

Locations

Manresa, Barcelona, Spain

Patients applied

0 patients applied

Trial Officials

Pablo Vega

Principal Investigator

Complexo Hospitalario de Ourense

Maria Luisa de Castro

Principal Investigator

Complexo Hospitalario Universitario de Vigo-CHUVI

Eva Martínez-Bauer

Principal Investigator

Corporacion Parc Tauli

Angel Fernández

Principal Investigator

Hospital Clínico de Zaragoza

Gema de la Poza

Principal Investigator

Hospital de Fuenlabrada

Jorge López

Principal Investigator

Hospital de Móstoles

Oscar Nogales

Principal Investigator

Gregorio Marañón Hospital

Beatriz Peñas

Principal Investigator

Hospital Universitario Ramon y Cajal

Pilar Díez

Principal Investigator

Hospital Río Ortega

Marta Hernández

Principal Investigator

Hospital Universitario Puerta de Hierro

Antonio Zebenzuy

Principal Investigator

Hospital Universitario de Canarias

Aurora Burgos

Principal Investigator

Hospital Universitario La Paz

Jorge Mendoza

Principal Investigator

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Marco Antonio Álvarez

Principal Investigator

Hospital del Mar

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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