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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02033980
Other study ID # rjxh[2013]125
Secondary ID
Status Not yet recruiting
Phase N/A
First received December 27, 2013
Last updated January 9, 2014
Start date January 2014
Est. completion date June 2015

Study information

Verified date January 2014
Source Shanghai Jiao Tong University School of Medicine
Contact Zhizheng Ge, MD,Ph.D
Phone 86-21-58752345
Email zhizhengge@aliyun.com
Is FDA regulated No
Health authority China: Ethics CommitteeChina: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 400
Est. completion date June 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University Shanghai

Sponsors (5)

Lead Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine Changhai Hospital, Chinese PLA General Hospital, Peking Union Medical College Hospital, Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
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