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临床试验/NCT02799420
NCT02799420已完成不适用

Role of Probe-based Confocal Laser Endomicroscopy Targeted Biopsy in the Molecular Study of Undifferentiated Gastric Cancer

Yonsei University2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2016年6月20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
74
试验地点
2
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. In previous pilot study in our institution, pCLE-targeted biopsy provided superior results in terms of the proportion of cancer cells in biopsy samples compared to WLE-targeted biopsy, especially for gastric cancers with undifferentiated histology. However, there was a limitation because of small sample size. Therefore, the investigators aim to evaluate that biopsy using probe-based confocal laser endomicroscopy for undifferentiated gastric cancer will increase the percentage of cancer cells and expression ratio of tumor marker 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

入选标准

  • A. Age, between 20 and 80 B. Patients with undifferentiated gastric cancer who will be underwent surgery

排除标准

  • A. Previous subtotal gastrectomy B. Previous EMR/ESD history C. Significant cardiopulmonary disease D. Active hepatitis or severe hepatic dysfunction E. Severe renal dysfunction F. Severe bone marrow dysfunction G. Severe neurologic or psychotic disorder H. Pregnancy or breast feeding

研究组 & 干预措施

pCLE group

Experimental

The intervention group

干预措施: GastroFlex UHD, Cellvizio; Mauna Kea Technologies, Paris, France (Device)

WLE group

Active Comparator

The control group

干预措施: white light endoscopy (WLE) (Device)

结局指标

主要结局

The percentage of cancer cells in biopsy samples

时间窗: Day 3

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

次要结局

  • The expression ratio of tumor marker in biopsy samples(Day 3)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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