Efficacy of NICE Classification in the Histological Evaluation of Colorectal Lesions

Shanghai Jiao Tong University School of Medicine

Status: Unknown

Conditions: Colorectal Polyps

Treatments: Device: NBI

Study type: Interventional

Funder types: Other

Identifiers

NCT02033980

rjxh[2013]125

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

colorectal lesions

Other group

Description:

All lesions will be observed with NBI and removed endoscopically or surgically for histological diagnosis.

Treatment:

Device: NBI