Efficacy of NICE Classification in the Histological Evaluation of Colorectal Lesions

Efficacy of NICE Classification in the Histological Evaluation of Colorectal Lesions ----- a Multicenter Study in China

Recently, a new category classification (NICE classification) using non-magnified NBI has been proposed. We design this multicenter study to evaluate the reliability and validity of the NICE classification in diagnosing colorectal polyps by Chinese endoscopists during both image and real-time process.

Study Overview

• Status: Unknown
• Conditions: Colorectal Polyps
• Intervention / Treatment: Device: NBI

Detailed Description

Many reports have demonstrated the efficacy of narrow band imaging (NBI) with magnification in predicting the histology and invasion depth of colorectal polyps. In China, however, the magnifying endoscope is not used in some medical centers. Even in centers equipped with this technique, the magnifying colonoscope is not sufficiently used in daily practice. Recently, a simple category classification (NICE classification) using non-magnified NBI has been proposed, which classifies colorectal tumors into types 1-3 based on different characteristics of color, surface pattern, and microvessels. Type-1 is considered an index for hyperplastic lesions, type-2 is an index for adenoma or mucosal/SM scanty invasive carcinoma and type-3 is an index for deep SM invasive carcinoma. The new classification has soon arouse attention and been validated in some centers on the efficacy of differentiating adenomatous and hyperplastic polyps. However, most studies enrolled diminutive polyps less than 5mm and the efficacy of non-magnified NBI in differentiating type-2 and type-3 lesions has not been reported. To promote this simple classification, we design this multicenter study to evaluate the predictive validity and performance characteristics of the non-magnified NBI in diagnosing polyps during both image and real-time process.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhizheng Ge, MD,Ph.D; Phone Number: 86-21-58752345; Email: zhizhengge@aliyun.com

Study Locations

• China
  • Shanghai, China, 200001
    • Recruiting
    • Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University
    • Principal Investigator: Zhizheng Ge, MD, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with colorectal lesions during colonoscopy examination
• Informed consent available

Exclusion Criteria:

• Suspect of advanced colorectal cancer
• History of colorectal surgery, familial adenomatous polyposis or inflammatory bowel disease
• Poor bowel preparation
• Patients under unsuitable conditions for examination or treatment, such as acute upper gastrointestinal bleeding, noncorrectable coagulopathy, severe systemic disease, etc

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: colorectal lesions; All lesions will be observed with NBI and removed endoscopically or surgically for histological diagnosis.	Device: NBI; All detected colorectal lesions will be examined by high-definition NBI. For type 2 and type 3 lesions, subsequent magnifying NBI examination will be performed.; Other Names: Evis Lucera system (CV-260, Olympus Inc, Japan); high-definition colonoscopes (CF-H260AL, Olympus Inc, Japan); magnifying colonoscopes (CF-H260AZL, Olympus Inc, Japan)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of NICE classification in histological prediction by gastroenterological fellows	Diagnostic accuracy of gastroenterological fellows using non-magnified NBI according to NICE classification in histological prediction of polyps, compared with histologic examination	within two weeks after polypectomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of high-definition and magnifying NBI for type 2 and type 3 lesions.	For lesions identified as type 2 or type 3, subsequent magnifying NBI examination will be performed by NBI experts. Before that, experts will make their own assessment according to all the images taken by gastroenterological fellows, blind to their diagnosis. Then experts will examine the lesions using magnifying endoscopy with NBI capability and make a new assessment.	two weeks after endoscopical or surgical resection

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Collaborators: Changhai Hospital; Peking University People's Hospital; Peking Union Medical College Hospital; Chinese PLA General Hospital
• Investigators: Principal Investigator: Zhizheng Ge, MD,Ph.D, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai ,China.

Publications and helpful links

General Publications

• Zhang QW, Zhang JJ, Yang AM, Sheng JQ, Liu YL, Li ZS, Chen HY, Feng N, Jiang QW, Jin P, Zhang LM, Fu HY, Gao YJ, Ge ZZ, Li XB. Feasibility of using narrow band imaging international colorectal endoscopic classification for diagnosing colorectal neoplasia in China: A multicenter pilot observational study. J Dig Dis. 2020 Feb;21(2):88-97. doi: 10.1111/1751-2980.12841.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (ANTICIPATED): June 1, 2017
• Study Completion (ANTICIPATED): August 1, 2017

Study Registration Dates

• First Submitted: December 27, 2013
• First Submitted That Met QC Criteria: January 9, 2014
• First Posted (ESTIMATE): January 13, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): May 10, 2016
• Last Update Submitted That Met QC Criteria: May 8, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: colorectal lesions; predicting histology; NICE classification; narrow band imaging(NBI)
• Other Study ID Numbers: rjxh[2013]125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED