Clinical trial NCT02328066: Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion
Official title: Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion in Colon Lesions. Prospective Multicenter Study in Routine Clinical Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Polyps
Keywords: NBI
NICE classification
deep submucosal invasion
Colonic Polyps [C23.300.825.411.235]
Colonoscopy [E01.370.372.250.250.200]
Lead sponsor: Asociación Española de Gastroenterología
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 2171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: 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 (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.

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).

Primary outcomes:
measure: Diagnostic accuracy of NICE classification to predict deep submucosal invasion
timeFrame: 1 year
Secondary outcomes:
measure: Diagnostic accuracy of NICE classification to predict deep submucosal invasion in the pre-learning test
timeFrame: 0
measure: Diagnostic accuracy of NICE classification to predict deep submucosal invasion in the post-learning test
timeFrame: 0
measure: Preplanned potential factors that could influence diagnostic accuracy of NICE classification
timeFrame: 1 year
measure: Histological predictors of lymph node metastases of pT1
timeFrame: 1 year
Other outcomes:
Locations:
city: Manresa
country: Spain
facility: Ignasi Puig
state: Barcelona
Study officials:
affiliation: Complexo Hospitalario de Ourense
name: Pablo Vega
role: PRINCIPAL_INVESTIGATOR
affiliation: Complexo Hospitalario Universitario de Vigo-CHUVI
name: Maria Luisa de Castro
role: PRINCIPAL_INVESTIGATOR
affiliation: Corporacion Parc Tauli
name: Eva Martínez-Bauer
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico de Zaragoza
name: Angel Fernández
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Fuenlabrada
name: Gema de la Poza
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Móstoles
name: Jorge López
role: PRINCIPAL_INVESTIGATOR
affiliation: Gregorio Marañón Hospital
name: Oscar Nogales
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Ramon y Cajal
name: Beatriz Peñas
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Río Ortega
name: Pilar Díez
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Puerta de Hierro
name: Marta Hernández
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Canarias
name: Antonio Zebenzuy
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario La Paz
name: Aurora Burgos
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: Jorge Mendoza
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital del Mar
name: Marco Antonio Álvarez
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.