Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion

Colonic Polyps Clinical Trial

— NICE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02328066
• Other study ID #: CEIC14/47
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: July 2016

Study information

• Verified date: June 2018
• Source: Asociación Española de Gastroenterología
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2171
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Colonic Polyps

Intervention

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.

Locations

Country	Name	City	State
Spain	Ignasi Puig	Manresa	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Asociación Española de Gastroenterología

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	0
Secondary	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)	0
Secondary	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
Secondary	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