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Completed

NCT Number: NCT02328066

Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion

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.

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Key information

Conditions

Colonic Polyps Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ignasi Puig

Manresa, Barcelona, 08241, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

NBI used by trained endoscopists

Device

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 outcomes

  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 outcomes

  1. Diagnostic accuracy of NICE classification to predict deep submucosal invasion in the pre-learning test

    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

    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).

Sponsors and collaborators

Lead sponsor

Asociación Española de Gastroenterología

Other

Registry information

Official study title

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

Acronym: NICE

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 31, 2014
Registry last updated
Jun 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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