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临床试验/NCT02089373
NCT02089373已完成不适用

A Pilot Study on Usefulness of Probe-based Confocal Laser Endomicroscopy Targeted Gastric Biopsy

Yonsei University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
The percentage of cancer cells in biopsy samples

研究概览

简要总结

The purpose of this study is to conduct a study on genetic pathology, obtaining of pure cancer tissues is mandatory. Although the endoscopy with biopsy has been a gold standard for diagnosing gastric cancer, percentage of cancer cells in biopsy samples is usually 30% or less. Recently, confocal laser endomicroscopy has been introduced for real-time histopathologic diagnosis in various cancers. The investigators aim to evaluate that biopsy using probe-based confocal laser endomicroscopy will increase the percentage of cancer cells in biopsy samples.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • •Age, between 20 and 80
  • •Initial-onset gastric cancer which would be treated with surgery

排除标准

  • •Previous subtotal gastrectomy
  • •Pregnancy or breast milk feeding
  • •Active infection
  • •Significant cardiopulmonary disease
  • •Active hepatitis or severe hepatic dysfunction
  • •Severe renal dysfunction
  • •Severe bone marrow dysfunction
  • •Severe neurologic or psychotic disorder

研究组 & 干预措施

Probe-based confocal laser endomicroscopy

Experimental

干预措施: Probe-based confocal laser endomicroscopy (Procedure)

White light endoscopy

Active Comparator

干预措施: White light endoscopy (Procedure)

结局指标

主要结局

The percentage of cancer cells in biopsy samples

时间窗: After 3 days from the end of the endoscopic submucosal dissection

The percentages of cancer cells in biopsy samples according to the method of endoscopic method, probe-based confocal laser endomicroscopy versus white light endosocpy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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