Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion (NICE)
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|ClinicalTrials.gov Identifier: NCT02328066|
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : June 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colonic Polyps||Device: NBI used by trained endoscopists||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2171 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion in Colon Lesions. Prospective Multicenter Study in Routine Clinical Practice|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
Experimental: 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.
Device: 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.
- Diagnostic accuracy of NICE classification to predict deep submucosal invasion [ Time Frame: 1 year ]
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)
- Diagnostic accuracy of NICE classification to predict deep submucosal invasion in the pre-learning test [ Time Frame: 0 ]Sensibility, specificity, negative predictive value and positive predictive value of NICE classification to predict deep submucosal invasion in the pre-learning test.
- Diagnostic accuracy of NICE classification to predict deep submucosal invasion in the post-learning test [ Time Frame: 0 ]Sensibility, specificity, negative predictive value and positive predictive value of NICE classification to predict deep submucosal invasion in the post-learning test (pre-clinical test)
- Preplanned potential factors that could influence diagnostic accuracy of NICE classification [ Time Frame: 1 year ]
Related to the lesion: Size (mm); location: rectum/sigmoid/left colon/splenic flexure/transverse colon/hepatic flexure/right colon and cecum; Morphology according to the Paris classification (see categories in the reference article); Level of confidence: high/low; Successful complete submucosal injection: yes/no/not done; Chicken skin's sign: yes/no; Edges retraction: yes/no; Depressed areas: yes/no; Folds convergence: yes/no; Induration: yes/no; Obvious ulceration: yes/no; Polyp on polyp: yes/no; Technical resection: 8 categories according to the current practice.
Related to the equipment: Colonoscope: 11 colonoscope models; Videoprocessor: Exera II, Exera III; Monitor: high definition, non-high definition
Related to the endoscopist: Hospital type: Secondary or tertiary; Endoscopy experience (number of years); Previous experience in chromoendoscopy: yes/no; Previous experience in NBI: yes/no; Number of lesions included in the study; Review histology and images monthly: yes/no
- Histological predictors of lymph node metastases of pT1 [ Time Frame: 1 year ]
- Histological type: adenocarcinoma, mucinous adenocarcinoma, cell carcinoma with signet ring, undifferentiated carcinoma, other.
- Histologic Grade: Low Grade (well-moderately differentiated) or High-grade (poorly dif, undifferentiated, mucinous, signet ring).
- Horizontal size of adenocarcinoma (mm)
- Level of submucosal adenocarcinoma (mm)
- Angiolymphatic invasion of small vessels: Present or absent
- Perineural invasion: Present or Absent.
- Tumor budding: Absent, Low grade (5-9 groups of 5 cells per field with 20x objective), High Grade (≥10 groups of 5 cells per field with 20x objective)
- Polyp type that originated carcinoma: Tubular adenoma, Villous adenoma, Adenoma/sessile serrated polyp, Traditional serrated adenoma, Other
- Resection margin: Negative or Positive
- Size of negative margin (mm).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328066
|Manresa, Barcelona, Spain, 08241|
|Principal Investigator:||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||Hospital La Princesa|
|Principal Investigator:||Marco Antonio Álvarez||Hospital del Mar|