NCT01179724Unknown不适用
Comparison of Proton Pump Inhibitor and H2 Receptor Blocker on Prevention of Bleeding From Iatrogenic Ulcer After Endoscopic Submucosal Dissection for Gastric Neoplasms: A Prospective Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- bleeding incidence after ESD
研究概览
简要总结
after endoscopic submucosal dissection(ESD) of early gastric cancer, conventional proton pump(PPI) inhibitors and H2 receptor antagonists have a controversial effect on preventing bleeding from artificial ulcers. the aim of this study was to investigate whether a stronger acid suppression (high dose PPI) more effectively prevents bleeding after ESD
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the patients who agreed informed consent
- •gastric adenoma or early gastric cancer which is eligible for conventional ESD indication
排除标准
- •recent drug history of PPI, H2 rector antagonist, bismuth and antibiotics within 4 weeks
- •recent drug history of anticoagulant or antiplatelet agent within 7 days
- •s/p subtotal gastrectomy
- •recurred gastric adenoma or cancer
- •pregnant or breast feeding patients
研究组 & 干预措施
high dose proton pump inhibitor
Experimental
干预措施: high dose proton pump inhibitor (Drug)
H2 receptor antagonist
Active Comparator
干预措施: H2RB (Drug)
结局指标
主要结局
bleeding incidence after ESD
时间窗: time to occur delayed bleeding within one month after ESD
次要结局
- the size of healing ulcer after ESD(follow up endoscopy for the healing of iatrogenic ulcer after one month ESD)
研究者
研究点 (1)
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