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Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion (NICE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02328066
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Asociación Española de Gastroenterología

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.

Condition or disease Intervention/treatment Phase
Colonic Polyps Device: NBI used by trained endoscopists Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2171 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonic Polyps

Arm Intervention/treatment
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.
Other Names:
  • Narrow Band Imaging
  • NICE classification




Primary Outcome Measures :
  1. 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)



Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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


  4. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

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


Locations
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Spain
Ignasi Puig
Manresa, Barcelona, Spain, 08241
Sponsors and Collaborators
Asociación Española de Gastroenterología
Investigators
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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
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Asociación Española de Gastroenterología
ClinicalTrials.gov Identifier: NCT02328066    
Other Study ID Numbers: CEIC14/47
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Keywords provided by Asociación Española de Gastroenterología:
NBI
NICE classification
deep submucosal invasion
Colonic Polyps [C23.300.825.411.235]
Colonoscopy [E01.370.372.250.250.200]
Additional relevant MeSH terms:
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Colonic Polyps
Polyps
Pathological Conditions, Anatomical
Intestinal Polyps