Usefulness of Near-focus With Narrow-band Imaging for Determining Gastric Tumor Margin
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
- 否
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
Jung-Wook Kim
Assistant Professor
Kyunghee University Medical Center
