Ignasi Puig1, María López-Cerón2, Anna Arnau3, Òria Rosiñol4, Miriam Cuatrecasas5, Alberto Herreros-de-Tejada6, Ángel Ferrández7, Miquel Serra-Burriel8, Óscar Nogales9, Francesc Vida10, Luisa de Castro11, Jorge López-Vicente12, Pablo Vega13, Marco A Álvarez-González14, Jesús González-Santiago15, Marta Hernández-Conde6, Pilar Díez-Redondo16, Liseth Rivero-Sánchez2, Antonio Z Gimeno-García17, Aurora Burgos18, Francisco Javier García-Alonso19, Marco Bustamante-Balén20, Eva Martínez-Bauer21, Beatriz Peñas22, Maria Pellise23. 1. Digestive Diseases Department, Althaia Xarxa Assistencial Universitària de Manresa, Barcelona, Spain; Universitat Internacional de Catalunya, Barcelona, Spain. Electronic address: ignasipuig@gmail.com. 2. Gastroenterology Department, Institut de Malalties Digestives i Metabòliques, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain. 3. Clinical Research Unit, Althaia Xarxa Assistencial Universitària de Manresa, Barcelona, Spain. 4. Pathology Department, Althaia Xarxa Assistencial Universitària de Manresa, Barcelona, Spain. 5. Pathology Department, Hospital Clínic, University of Barcelona, Barcelona, Spain; Banc de Tumors, Biobanc Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain. 6. Gastroenterology Department, Research Institute Segovia Arana, Hospital Universitario Puerta de Hierro, Madrid, Spain. 7. Digestive Diseases Department, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Biomedical Research Networking Center in Hepatic and Digestive Diseases, Madrid, Spain. 8. Center for Research in Health and Economics, Universitat Pompeu Fabra, Barcelona, Spain. 9. Digestive Diseases Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain. 10. Digestive Diseases Department, Althaia Xarxa Assistencial Universitària de Manresa, Barcelona, Spain. 11. Digestive Diseases Department, Complexo Hospitalario Universitario de Vigo, Vigo, Spain. 12. Digestive Diseases Department, Hospital Universitario de Móstoles, Madrid, Spain. 13. Digestive Diseases Department, Complexo Hospitalario Universitario de Ourense, Ourense, Spain. 14. Digestive Diseases Department, Hospital del Mar, Barcelona, Spain. 15. Digestive Diseases Department, Complejo Asistencial Universitario de Salamanca, Instituto de Investigación Biomédica de Salamanca, Salamanca, Spain. 16. Digestive Diseases Department, Hospital Universitario Río Hortega, Valladolid, Spain. 17. Digestive Diseases Department, Hospital Universitario de Canarias, Tenerife, Spain. 18. Digestive Diseases Department, Hospital Universitario La Paz, Madrid, Spain. 19. Digestive Diseases Department, Hospital Universitario de Fuenlabrada, Madrid, Spain. 20. Digestive Diseases Department, Hospital Universitario y Politécnico de La Fe, Valencia, Spain. 21. Digestive Diseases Department, Corporació Sanitària Parc Taulí, Barecelon, Spain. 22. Digestive Diseases Department, Hospital Universitario Ramón y Cajal, Madrid, Spain. 23. Gastroenterology Department, Institut de Malalties Digestives i Metabòliques, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Biomedical Research Networking Center in Hepatic and Digestive Diseases, Madrid, Spain.
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 polyps 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 end point 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 (P < .001). However, pedunculated morphology (P < .007), ulceration (P = .026), depressed areas (P < .001), or nodular mixed type (P < .001) affected accuracy of identification. Results were comparable for identifying lesions that were endoscopically unresectable. CONCLUSIONS: In an analysis of 2123 colon lesions >10 mm, we found the NICE classification and morphologic features identify those with deep lesions with >96% specificity-even in non-expert hands and without magnification. ClinicalTrials.gov number NCT02328066.
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 polyps 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 end point 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 (P < .001). However, pedunculated morphology (P < .007), ulceration (P = .026), depressed areas (P < .001), or nodular mixed type (P < .001) affected accuracy of identification. Results were comparable for identifying lesions that were endoscopically unresectable. CONCLUSIONS: In an analysis of 2123 colon lesions >10 mm, we found the NICE classification and morphologic features identify those with deep lesions with >96% specificity-even in non-expert hands and without magnification. ClinicalTrials.gov number NCT02328066.
Authors: Jasper L A Vleugels; Lianne Koens; Marcel G W Dijkgraaf; Britt Houwen; Yark Hazewinkel; Paul Fockens; Evelien Dekker Journal: Gut Date: 2019-12-10 Impact factor: 23.059