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临床试验/NCT03238573
NCT03238573Unknown不适用

The Real-time Optical Diagnosis Value of Optical Enhancement Endoscopy in Colorectal Sessile Serrated Adenomas/Polyps :A Prospective Study

Shandong University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年7月19日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Real-time diagnosis accuracy of optical enhancement in colorectal sessile serrated adenomas/polyps

研究概览

简要总结

When a polyp is found, we begin to wash it and observe it with OE mode 1.Then,the endoscopist gives a real-time optical diagnosis and the future surveillance interval.Finally,the polyp will be resected for the biopsy.

详细描述

When discovering a polyp, the endoscopist uses water to wash it.Then, the endoscopist starts with i-scan 1 (OE mode 1) to observe the polyp closely .Nextly, the endoscopist give a real-time optical diagnosis with the blind of the history of patient. Considering the other polyps, the endoscopist gives a surveillance interval predictions according to the guide made by USMSTF.The confidence of the real-time optical diagnosis is divided into high confidence and low confidence.After the observation, the small and diminutive polyp will be resected and have the blinded pathology.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The high risk for colorectal cancer screening score
  • Patients with colorectal polyps reviewing

排除标准

  • 1.Inflammatory bowel disease
  • Polyposis syndrome
  • A history of colorectal cancer or surgical resection
  • Poor bowel preparation5.Not signing the informed consent 6.Severe cardiopulmonary function failure lesions, severe hypertension, cerebrovascular disease, mental disorder and coma, pregnancy, lactation can't taking the colonoscopy.

结局指标

主要结局

Real-time diagnosis accuracy of optical enhancement in colorectal sessile serrated adenomas/polyps

时间窗: 2years

次要结局

  • Real-time diagnosis accuracy of optical enhancement in colorectal adenomas and hyperplastic polyps(2 years)

研究者

发起方
Shandong University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanqing Li

Vice president of Qilu Hospital

Shandong University

研究点 (1)

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