NCT02328066

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,171

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2014

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

2 years

First QC Date

December 8, 2014

Last Update Submit

June 26, 2018

Conditions

Colonic Polyps

Keywords

NBINICE classificationdeep submucosal invasionColonic Polyps [C23.300.825.411.235]Colonoscopy [E01.370.372.250.250.200]

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of NICE classification to predict deep submucosal invasion

    Sensibility, specificity, negative predictive value and positive predictive value of NICE classification to predict deep submucosal invasion during routine colonoscopies. Gold standard (histology): * positive means adenocarcinoma with deep submucosal invasion (\>1 mm) * negative means non adenocarcinoma or superficial adenocarcinoma (\<1 mm) Evaluated test (NICE classification): * Positive means NICE type 3. * Negative means NICE type 1 and 2. Evaluated test (NICE classification) was blinded to the pathologist who performed the gold standard test (histology)

    1 year

Secondary Outcomes (4)

  • Diagnostic accuracy of NICE classification to predict deep submucosal invasion in the pre-learning test

    0

  • Diagnostic accuracy of NICE classification to predict deep submucosal invasion in the post-learning test

    0

  • Preplanned potential factors that could influence diagnostic accuracy of NICE classification

    1 year

  • Histological predictors of lymph node metastases of pT1

    1 year

Study Arms (1)

NBI used by trained endoscopists

EXPERIMENTAL

Assessment with NICE classification and NBI technology of colonic lesions (Paris classification type 0) greater than 1 cm found in a routine colonoscopy. This assessment was performed by previously trained endoscopists.

Device: NBI used by trained endoscopists

Interventions

NBI used by trained endoscopistsDEVICE

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.

Also known as: Narrow Band Imaging, NICE classification
NBI used by trained endoscopists

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Ignasi Puig

Manresa, Barcelona, 08241, Spain

Location

Related Publications (2)

  • Hayashi N, Tanaka S, Hewett DG, Kaltenbach TR, Sano Y, Ponchon T, Saunders BP, Rex DK, Soetikno RM. Endoscopic prediction of deep submucosal invasive carcinoma: validation of the narrow-band imaging international colorectal endoscopic (NICE) classification. Gastrointest Endosc. 2013 Oct;78(4):625-32. doi: 10.1016/j.gie.2013.04.185. Epub 2013 Jul 30.

    PMID: 23910062BACKGROUND

  • Puig I, Lopez-Ceron M, Arnau A, Rosinol O, Cuatrecasas M, Herreros-de-Tejada A, Ferrandez A, Serra-Burriel M, Nogales O, Vida F, de Castro L, Lopez-Vicente J, Vega P, Alvarez-Gonzalez MA, Gonzalez-Santiago J, Hernandez-Conde M, Diez-Redondo P, Rivero-Sanchez L, Gimeno-Garcia AZ, Burgos A, Garcia-Alonso FJ, Bustamante-Balen M, Martinez-Bauer E, Penas B, Pellise M; EndoCAR group, Spanish Gastroenterological Association and the Spanish Digestive Endoscopy Society. Accuracy of the Narrow-Band Imaging International Colorectal Endoscopic Classification System in Identification of Deep Invasion in Colorectal Polyps. Gastroenterology. 2019 Jan;156(1):75-87. doi: 10.1053/j.gastro.2018.10.004. Epub 2018 Oct 6.

    PMID: 30296432DERIVED

MeSH Terms

Conditions

Colonic Polyps

Interventions

Narrow Band Imaging

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Pablo Vega

    Complexo Hospitalario de Ourense

    PRINCIPAL INVESTIGATOR

  • Maria Luisa de Castro

    Complexo Hospitalario Universitario de Vigo-CHUVI

    PRINCIPAL INVESTIGATOR

  • Eva Martínez-Bauer

    Corporacion Parc Tauli

    PRINCIPAL INVESTIGATOR

  • Angel Fernández

    Hospital Clínico de Zaragoza

    PRINCIPAL INVESTIGATOR

  • Gema de la Poza

    Hospital de Fuenlabrada

    PRINCIPAL INVESTIGATOR

  • Jorge López

    Hospital de Móstoles

    PRINCIPAL INVESTIGATOR

  • Oscar Nogales

    Gregorio Marañón Hospital

    PRINCIPAL INVESTIGATOR

  • Beatriz Peñas

    Hospital Universitario Ramon y Cajal

    PRINCIPAL INVESTIGATOR

  • Pilar Díez

    Hospital Río Ortega

    PRINCIPAL INVESTIGATOR

  • Marta Hernández

    Hospital Universitario Puerta de Hierro

    PRINCIPAL INVESTIGATOR

  • Antonio Zebenzuy

    Hospital Universitario de Canarias

    PRINCIPAL INVESTIGATOR

  • Aurora Burgos

    Hospital Universitario La Paz

    PRINCIPAL INVESTIGATOR

  • Jorge Mendoza

    Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

    PRINCIPAL INVESTIGATOR

  • Marco Antonio Álvarez

    Hospital del Mar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2014

First Posted

December 31, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

June 27, 2018

Record last verified: 2018-06

Locations

ES(1)