Efficacy of WASP Classification in the Histological Evaluation of Diminutive Colorectal Polyps
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,640
- 试验地点
- 2
- 主要终点
- Negative predictive value of diminutive polyps located in rectum and sigmoid colon under high confidence of diagnosis
研究概览
简要总结
Adenomas, serrated adenomas and hyperplastic polyps are polypoid lesion in the colorectum. At the present moment, all polyps should be resected endoscopically, although only adenomas and serrated adenomas, but not hyperplastic polyps have the potential to develop colorectal cancer. Some studies have investigated the value of the narrow-band imaging (NBI) on histological prediction of the polyp. This method is conducted in real time during colonoscopy, which leads to simplification of diagnostic procedures. For instance, it would be conceivable to resect diminutive polyps and discard them without further assessment by a pathologist. One problem in this context is a correct differentiation between hyperplastic polyps and serrated adenomas. These two polyp entities are known to show similar optical features. However, while serrated adenomas are premalignant lesions hyperplastic polyps have benign histology and never develop into cancer. It is therefore important to sufficiently distinguish hyperplastic polyps from serrated lesions.
In this study the investigators want to investigate whether the use of NBI would be capable to get accuracy of optical polyp predictions by more than 90% using the WASP (Workgroup serrAted polypS and Polyposis) classification. NBI is a light filter tool which can be activated by pressing a button at the endoscope. The use of NBI leads to an endoscopic picture which appears blue and enables endoscopists to better assess surface structures and vascular patterns. All polyps will be resected and send to pathology for further microscopic assessment. After completing the trial the investigators aim to compare accuracy of the optical diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Endoscopists did not know histology of diminutive colorectal polyps
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged more than 18 years old
- •Patients with at least one diminutive colorectal polyp
排除标准
- •Patients with poor bowel preparation
- •Paitents with history of colorectal surgery, familial adenomatous polyposis or inflammatory bowel disease
- •Patients with advanced colorectal cancer
- •Patients with missed histology information of resected polyps or missed resected specimen
- •Patients with emergency operation during colonoscopy
- •Patients with unfinished colonoscopy due to any reason
结局指标
主要结局
Negative predictive value of diminutive polyps located in rectum and sigmoid colon under high confidence of diagnosis
时间窗: Within two weeks after polypectomy
Accuracy of WASP classification in histological prediction of diminutive polyps under high confidence of diagnosis
时间窗: Within two weeks after polypectomy
Accuracy of Surveillance time prediction of patients with at least one diminutive polyps under high confidence of diagnosis
时间窗: Within two weeks after polypectomy
次要结局
- Learning curve of accuracy of endoscopists using NBI in assessment of diminutive polyps(Within two weeks after polypectomy)
研究者
Zhizheng Ge
MD,Ph.D
Shanghai Jiao Tong University School of Medicine
