跳至主要内容
临床试验/NCT02760381
NCT02760381Unknown不适用

Acetic Acid for Optical Characterization of Colonic Polyps: A Feasibility Study

Technical University of Munich2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2016年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
55
试验地点
2
主要终点
Diagnostic test: Optical characterization of colon polyps

研究概览

简要总结

Adenomas and hyperplastic polyps are polypoid lesions that can occur in any part of the colon. Currently all polyps should be resected endoscopically, however adenomas have the potential to develop into colorectal cancer whereas hyperplastic polyps do not. This approach enables the lesions to be evaluated under the microscope. Currently only the pathological diagnosis can distinguish exactly between adenomas and hyperplastic polyps. Acetic acid (AA) chromoendoscopy is already widely used in order to improve optical determination of mucosal lesions in the upper gastrointestinal tract. In the colon only few studies investigated the impact of AA in differentiating normal mucosa from suspicious mucosa. The aim of the present study is to evaluate the value of spraying acetic acid as an adjunct for optical characterization of colon polyps. Using AA may be beneficial for determining optical diagnoses of colon polyps during real time colonoscopy. This is a single-arm proof of principle study. If colon polyps are found during colonoscopy a 1.5 percent AA solution will be used for chromoendoscopy. Endoscopists are encouraged to use the Narrow Band Imaging (NBI) function of the endoscope prior to the use of AA. After AA is sprayed endoscopists will diagnose the polyp optically. Endoscopists have to predict adenomatous or non-adenomatous histology based upon optical features of the polyp. All polyps will be resected endoscopically so that histopathological diagnoses can be determined. After completing the trial the investigators aim to compare optical and histopathological-based diagnoses of polyps. Histopathological diagnoses will serve as the gold standard. Based upon this information the accuracy of the optical diagnoses will be calculated. The investigators hypothesis is, that optical-based diagnosis using NBI and AA will be accurate in > 75% of all polyp cases.

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

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • indication for colonoscopy

排除标准

  • pregnant women
  • emergency investigation
  • history of inflammatory bowel disease
  • contraindication for polyp resection

结局指标

主要结局

Diagnostic test: Optical characterization of colon polyps

时间窗: up to 2 weeks

Optical diagnosis of polyp histology will be assessed within a period of 2 weeks

次要结局

未报告次要终点

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Sponsor

研究点 (2)

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