Clinical trial NCT02033980: Efficacy of NICE Classification in the Histological Evaluation of Colorectal Lesions
Official title: Efficacy of NICE Classification in the Histological Evaluation of Colorectal Lesions ----- a Multicenter Study in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Polyps
Keywords: narrow band imaging(NBI)
NICE classification
colorectal lesions
predicting histology
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Changhai Hospital
name: Peking University People's Hospital
name: Peking Union Medical College Hospital
name: Chinese PLA General Hospital
First posted: 2014-01-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of NICE classification in histological prediction by gastroenterological fellows
timeFrame: within two weeks after polypectomy
Secondary outcomes:
measure: Diagnostic accuracy of high-definition and magnifying NBI for type 2 and type 3 lesions.
timeFrame: two weeks after endoscopical or surgical resection
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai ,China.
name: Zhizheng Ge, MD,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.