Clinical Trial: Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion in Colon Lesions. Prospective Multicenter Study in Routine Clinical Practice

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 Summary:

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.


Sponsor: Asociación Española de Gastroenterología

Current Primary Outcome: 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)



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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).


Original Secondary Outcome: Same as current

Information By: Asociación Española de Gastroenterología

Dates:
Date Received: December 8, 2014
Date Started: July 2014
Date Completion: December 2015
Last Updated: December 26, 2014
Last Verified: December 2014