NCT01758965已完成不适用
Surgicel® (Fibrillar) for Preventing Delayed Bleeding After ESD in Stomach: A Prospective Randomized Study
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
- 146
- 试验地点
- 1
- 主要终点
- Delayed bleeding rate after ESD
研究概览
简要总结
The aim of this study is to assess the effect of Surgicel® Fibrillar as adjuvant treatment to H2RA on preventing ulcer bleeding after ESD for gastric epithelial tumors
详细描述
- Patient (1) Inclusion: Diagnosed as gastric dysplasia or early gastric cancer
- Scheduled for ESD (2) Exclusion: Coagulopathy- liver cirrhosis, thrombocytopenia
- Anti-platelet agents
- Method
(1) Study group: combination with Surgicel® Fibrillar and H2RA (2) Control group: monotherapy with PPI 3. Sample size : 157 4. Result
- Primary endpoint: rate of delayed bleeding after ESD
- Secondary endpoint: follow-up hemoglobin 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ESD for gastric dysplasia or early gastric cancer
排除标准
- •Coagulopathy: liver cirrhosis, thrombocytopenia
- •Anti-platelet agents
研究组 & 干预措施
combination therapy of H2RA and surgicel
Experimental
H2RA and surgicel
干预措施: H2RA and surgicel (Other)
Monotherapy of PPI
Experimental
PPI
干预措施: PPI (Other)
结局指标
主要结局
Delayed bleeding rate after ESD
时间窗: 1 year
次要结局
未报告次要终点
研究者
Su Jin Hong
MD, PhD
Soonchunhyang University Hospital
研究点 (1)
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