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临床试验/NCT03449966
NCT03449966Unknown不适用

Comparison of Ability of pCLE and WLE for Diagnosis and Cancer Tissue Acquisition in Advanced Gastric Cancer After Chemotherapy Status

Yonsei University2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2018年2月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
55
试验地点
2
主要终点
The percentage of remnant cancer cells in biopsy samples

研究概览

简要总结

* single center, prospective study First, evaluate the lesion under the white light endoscopy (WLE) → IV fluorescein sodium 0.1mL/kg → evaluate the lesion under probe-based confocal laser microendoscopy → target biopsy under the pCLE → random biopsy under WLE

详细描述

The purpose of this study is to conduct a study on genetic pathology, obtaining of 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 of patients after chemotherapy is usually 30% or less. Because cancer cells are often replaced with regenerative cells after chemotherapy, even though there are still remnant cancer cells in the stomach. 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 no previous study about precious biopsy method for patients after chemotherapy. Therefore, the investigators aim to evaluate that biopsy using probe-based confocal laser endomicroscopy for remnant gastric cancer after chemotherapy 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
Non Randomized
干预模型
Crossover
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. Older than 20 years old and younger than 80 years old B. Patients who completed neoadjuvant chemotherapy with AGC C. Patients who underwent palliative chemotherapy with AGC

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

Target biopsy under pCLE

Experimental

(Cellvisio® with confocal minoprobe™, Mauna Kea Technologies, France)

干预措施: Confocal group (Device)

Random biopsy at cancer lesion under WLE

Active Comparator

WLE (GIF-HQ290, Olympus, Japan) group

干预措施: Control group (Device)

结局指标

主要结局

The percentage of remnant cancer cells in biopsy samples

时间窗: within the first day after pCLE

The percentage of remnant 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

  • pCLE findings of residual cancer cells after chemotherapy(within the first day after pCLE)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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