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临床试验/NCT02217449
NCT02217449已完成不适用

Virtual Chromoendoscopy for Distal Polyps

University of Erlangen-Nürnberg Medical School1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
230
试验地点
1
主要终点
Effectivity of virtual chromoendoscopy

研究概览

简要总结

To assess the accuracy of predicting histology with virtual chromoendoscopy for distal colorectal polyps according to the ASGE PIVI statement.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Written informed consent
  • Screening or surveillance colonoscopy

排除标准

  • history of inflammatory bowel disease
  • poor bowel preparation
  • colectomy
  • anticoagulation
  • polyposis syndrome

结局指标

主要结局

Effectivity of virtual chromoendoscopy

时间窗: 3 years

Upon visualization of a polyp in white-light, the location and size (as compared to open biopsy forceps or snare) are noted. Afterwards, virtual chromoendoscopy is used to visualize and enhance the mucosal vascular pattern and the mucosal surface pattern morphology of the polyp. The endoscopist makes a real time assessment of each polyp according to size, shape, Paris classification and surface characteristics including pit pattern and mucosal vascular pattern morphology, colour, and type of depression. Further, the endoscopist is assigning a level of confidence (high or low) to each real time prediction. Afterwards, all polyps are resected using standard techniques and processed for pathological evaluation. Each polyp is assessed by an experienced GI pathologist blinded to the real time prediction of polyp histology. Finally, real time and histological results are compared.

次要结局

未报告次要终点

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Sponsor

研究点 (1)

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