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| Name | Class |
|---|---|
| Changhai Hospital | OTHER |
| Peking University People's Hospital | OTHER |
| Peking Union Medical College Hospital | OTHER |
| Chinese PLA General Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| colorectal lesions | Other | All lesions will be observed with NBI and removed endoscopically or surgically for histological diagnosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBI | Device | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhizheng Ge, MD,Ph.D | Contact | 86-21-58752345 | zhizhengge@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhizheng Ge, MD,Ph.D | Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai ,China. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University | Recruiting | Shanghai | 200001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31895484 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 19, 2019 | |
| Reset | Sep 26, 2019 | |
| Release | May 17, 2022 | |
| Reset | Feb 16, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 19, 2019 | Sep 26, 2019 | |||
| May 17, 2022 |
| OTHER |
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| two weeks after endoscopical or surgical resection |
| Feb 16, 2023 |