Gastroenterology

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Gastroenterology Accuracy of the NICE Classification System in Identification of Deep Invasion in Colon Polyps --Manuscript Draft-Manuscript Number:

GASTRO-D-18-00505R2

Full Title:

Accuracy of the NICE Classification System in Identification of Deep Invasion in Colon Polyps

Article Type:

Clinical - Alimentary Tract

Section/Category:

Clinical

Corresponding Author:

Ignasi Puig, MD, PhD Althaia Xarxa Assistencial Universitària de Manresa Manresa, SPAIN

Corresponding Author Secondary Information: Corresponding Author's Institution:

Althaia Xarxa Assistencial Universitària de Manresa

Corresponding Author's Secondary Institution: First Author:

Ignasi Puig, MD, PhD

First Author Secondary Information: Order of Authors:

Ignasi Puig, MD, PhD María López-Cerón, MD, PhD Anna Arnau, MsC, PhD Òria Rosiñol, MD Míriam Cuatrecasas, MD, PhD Alberto Herreros-de-Tejada, MD, PhD Ángel Ferrández, MD, PhD Miquel Serra-Burriel, MsC, PhD Óscar Nogales, MD Francesc Vida, MD Luisa de Castro, MD, PhD Jorge López-Vicente, MD Pablo Vega, MD Marco Antonio Álvarez-González, MD, PhD Jesús M. González-Santiago, MD Marta Hernández-Conde, MD Pilar Díez-Redondo, MD, PhD Liseth Rivero Sánchez, MD Antonio Z. Gimeno-García, MD, PhD Aurora Burgos, MD, PhD Francisco Javier García-Alonso, MD Marco Bustamante-Balén, MD, PhD

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Eva Martínez-Bauer, MD, PhD Beatriz Peñas, MD Maria Pellise, MD, PhD Order of Authors Secondary Information: Abstract:

Background & Aims: T1 colorectal polyps with at least 1 risk factor for metastasis to lymph node should be treated surgically and are considered endoscopically unresectable. Optical analysis, based on the narrow-band imaging international colorectal endoscopic (NICE) classification system, is used to identify neoplasias with invasion of the submucosa that require endoscopic treatment. We assessed the accuracy of the NICE classification, along with other morphologic characteristics, in identifying invasive polys that are endoscopically unresectable (have at least 1 risk factor for metastasis to lymph node). Methods: We performed a multicenter, prospective study of data collected by 58 endoscopists, from 1634 consecutive patients (examining 2123 lesions) at 17 university and community hospitals in Spain, from July 2014 through June 2016. All consecutive lesions >10 mm assessed with narrow-band imaging were included. The primary endpoint was the accuracy of the NICE classification for identifying lesions with deep invasion, using findings from histology analysis as the reference standard. Conditional inference trees were fitted for the analysis of diagnostic accuracy. Results: Of the 2123 lesions analyzed, 89 (4.2%) had features of deep invasion and 91 (4.3%) were endoscopically unresectable. The NICE classification system identified lesions with deep invasion with 58.4% sensitivity (95% CI, 47.5-68.8), 96.4% specificity (95% CI, 95.5-97.2), a positive-predictive value of 41.6% (95% CI, 32.9-50.8), and a negative-predictive value of 98.1% (95% CI, 97.5-98.7). A conditional inference tree that included all variables found the NICE classification to most accurately identify lesions with deep invasion (P20 lesions in the study, and location in the rectum. The level of statistical significance was two-sided 5% (p