Colorectal Polyps Clinical Trial
Official title:
Efficacy of NICE Classification in the Histological Evaluation of Colorectal Lesions ----- a Multicenter Study in China
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.
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
China | Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University | Shanghai |
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 |
China,
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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