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临床试验/NCT03903497
NCT03903497Unknown不适用

Efficacy of WASP Classification in the Histological Evaluation of Diminutive Colorectal Polyps

Shanghai Jiao Tong University School of Medicine2 个研究点 分布在 1 个国家目标入组 2,640 人开始时间: 2019年4月15日最近更新:
适应症

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

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

发起方
Shanghai Jiao Tong University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhizheng Ge

MD,Ph.D

Shanghai Jiao Tong University School of Medicine

研究点 (2)

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