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

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

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.

Study Overview

• Status: Completed
• Conditions: Colonic Polyps
• Intervention / Treatment: Device: NBI used by trained endoscopists

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.

• Study Type: Interventional
• Enrollment (Actual): 2171
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Manresa, Barcelona, Spain, 08241
      • Ignasi Puig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of NICE classification to predict deep submucosal invasion	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)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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)
Preplanned potential factors that could influence diagnostic accuracy of NICE classification	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	1 year
Histological predictors of lymph node metastases of pT1	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).	1 year

Collaborators and Investigators

• Sponsor: Asociación Española de Gastroenterología
• Investigators: 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 Mostoles; Principal Investigator: Oscar Nogales, Gregorio Marañon 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 and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: December 8, 2014
• First Submitted That Met QC Criteria: December 26, 2014
• First Posted (Estimate): December 31, 2014

Study Record Updates

• Last Update Posted (Actual): June 27, 2018
• Last Update Submitted That Met QC Criteria: June 26, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: NBI; NICE classification; deep submucosal invasion; Colonic Polyps [C23.300.825.411.235]; Colonoscopy [E01.370.372.250.250.200]
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Colonic Polyps
• Other Study ID Numbers: CEIC14/47