Efficacy of NICE Classification in the Histological Evaluation of Colorectal Lesions

Not Applicable

• Conditions: Colorectal Polyps

• Registration Number: NCT02033980
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

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.

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 Timeline

• Study First Submitted: 2013-12-27
• Study First Submitted QC: 2014-01-09
• Study First Posted: 2014-01-13
• Status Verified: 2016-05
• Study Start: 2016-05
• Last Update Submitted: 2016-05-08
• Last Update Posted: 2016-05-10
• Primary Completion: 2017-06
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Diagnostic accuracy of high-definition and magnifying NBI for type 2 and type 3 lesions.	two weeks after endoscopical or surgical resection	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.

Trial Locations

Locations (1)

Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University; 🇨🇳 Shanghai, China