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临床试验/NCT02661945
NCT02661945已完成不适用

Usefulness of Near-focus With Narrow-band Imaging for Determining Gastric Tumor Margin

Kyunghee University Medical Center14 个研究点 分布在 2 个国家目标入组 444 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
444
试验地点
14
主要终点
Accuracy (accurate if the distance (between margin dots and tumor margin measured by histopathology) was less than 1 mm)

研究概览

简要总结

Near-focus with narrow-band imaging is a novel technique to improve the quality of images of the irregular mucosal structures and microvessels of gastric neoplasms. The investigators compare this technique with indio carmin spray, commonly used tool to determine tumor margin. The subject are patients who underwent endoscopic submucosal dissection for gastric neoplasms. Participants are randomized into near-focus with narrow-band imaging and indigo carmin groups. First, marking is performed at the tumor margins determined by each modality. The distance from the marking dots to the tumor margin is measured histopathologically in the resected specimens. Finally, the investigators will compare the accuracy between two groups based on the distance from marking dots to tumor margin measured by histopathologic examination.

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants who undergo endoscopic submucosal dissection for gastric tumors (early gastric carcinoma or gastric adenoma)

排除标准

  • fail to en bloc resection

结局指标

主要结局

Accuracy (accurate if the distance (between margin dots and tumor margin measured by histopathology) was less than 1 mm)

时间窗: 1 week after procedure

Marking was diagnosed as accurate if the distance (between margin dots and tumor margin measured by histopathology) was less than 1 mm

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jung-Wook Kim

Assistant Professor

Kyunghee University Medical Center

研究点 (14)

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