Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion
NCT ID: NCT02328066
Last Updated: 2018-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2171 participants
INTERVENTIONAL
2014-07-31
2016-07-31
Brief Summary
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Detailed Description
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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 (NICE classification) was blinded to the pathologist who performed the gold standard test (histology). In case of adenocarcinomas, histological predictors of lymph node metastases, with predefined assessment criteria, will also be recorded.
Finally, histological preparations of adenocarcinomas will be sent to the reference center and two experienced pathologists will examine them again.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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NBI used by trained endoscopists
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Asociación Española de Gastroenterología
OTHER
Responsible Party
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Principal Investigators
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Pablo Vega
Role: PRINCIPAL_INVESTIGATOR
Complexo Hospitalario de Ourense
Maria Luisa de Castro
Role: PRINCIPAL_INVESTIGATOR
Complexo Hospitalario Universitario de Vigo-CHUVI
Eva Martínez-Bauer
Role: PRINCIPAL_INVESTIGATOR
Corporacion Parc Tauli
Angel Fernández
Role: PRINCIPAL_INVESTIGATOR
Hospital Clínico de Zaragoza
Gema de la Poza
Role: PRINCIPAL_INVESTIGATOR
Hospital de Fuenlabrada
Jorge López
Role: PRINCIPAL_INVESTIGATOR
Hospital de Móstoles
Oscar Nogales
Role: PRINCIPAL_INVESTIGATOR
Gregorio Marañón Hospital
Beatriz Peñas
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Ramon y Cajal
Pilar Díez
Role: PRINCIPAL_INVESTIGATOR
Hospital Río Ortega
Marta Hernández
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Puerta de Hierro
Antonio Zebenzuy
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario de Canarias
Aurora Burgos
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario La Paz
Jorge Mendoza
Role: PRINCIPAL_INVESTIGATOR
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Marco Antonio Álvarez
Role: PRINCIPAL_INVESTIGATOR
Hospital del Mar
Locations
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Ignasi Puig
Manresa, Barcelona, Spain
Countries
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References
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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.
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.
Other Identifiers
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CEIC14/47
Identifier Type: -
Identifier Source: org_study_id
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