NCT02189226已完成不适用
Usefulness of Probe-based Confocal Laser Endo-microscopy in Delineation of Margin of Early Gastric Cancer for Endoscopic Submucosal Dissection
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
- 101
- 试验地点
- 2
- 主要终点
- Complete resection rate
研究概览
简要总结
The aim of this study is to evaluate the usefulness of pCLE (probe-based confocal laser endomicroscopy) compared with conventional chromoendoscopy (CE) for delineating the margin of early gastric cancer (EGC) with endoscopic submucosal dissection (ESD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients diagnosed as EGC and treated by ESD with following criteria:1) Differentiated mucosal cancer without ulcer 2) Differentiated mucosal cancer with ulcer, ≤ 3 cm 3) Differentiated minute (<500 μm) submucosal invasive cancer, ≤ 3 cm 4) Undifferentiated mucosal cancer without ulcer, ≤ 2 cm
- •Consecutive patients diagnosed as low- and high-grade dysplasia with suspicion of EGC and treated by ESD
排除标准
- •Coagulopathy : International normalized ratio [INR] > 1.5 or platelet count <50,000 cell/cubic millimeter)
- •Impaired renal function : Cr > 1.2 mg/dL
- •Pregnancy or breast-feeding
- •Age < 20 years
- •Allergy to fluorescein dye
- •Inability to provide informed consent
研究组 & 干预措施
probe-based confocal laser endomicroscopy (pCLE) group
Experimental
干预措施: Endoscopic submucosal dissection (ESD) with or without probe-based confocal laser endomicroscopy (pCLE) (Device)
chromoendoscopy (CE) group
Active Comparator
干预措施: Endoscopic submucosal dissection (ESD) with or without probe-based confocal laser endomicroscopy (pCLE) (Device)
结局指标
主要结局
Complete resection rate
时间窗: One week after ESD
Complete resection is defined as en bloc resection with negative horizontal, vertical margin and distance from marking dot to histologic margin will be measured.
次要结局
- vertical cut end-positive(Within the first 30 days after ESD)
- procedure time(1 day)
- Horizontal cut end-positive(Within the first 30 days after ESD)
- adverse event(Within the first 30 days after ESD)
研究者
研究点 (2)
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