Efficacy of NICE Classification in the Histological Evaluation of Colorectal Lesions

Colorectal Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02033980
• Other study ID #: rjxh[2013]125
• 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

• Colorectal Polyps

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