Is Rebamipide Effective on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection? : Multicenter, Randomized, and Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Healing efficacy of Rebamipide in the treatment of iatrogenic gastric ulcer
研究概览
简要总结
Treatment strategy of post endoscopic submucosal dissection (ESD) ulcer is not yet conclusive. Rebamipide is a mucosal protective agent widely used in East Asia and has good effect on quality of ulcer healing (QOUH). The investigators will conduct this randomized controlled study to assess the effect of a combination therapy of rebamipide and proton pump inhibitor (PPI) on post ESD ulcer healing.
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
- 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
- •patients underwent ESD for gastric adenoma or cancer
排除标准
- •subjects with previous gastric surgery
- •subjects taking aspirin, anticoagulant, or antiplatelet agent
- •subjects having malignancy except gastric cancer
- •pregnant or breast-feeding women
研究组 & 干预措施
Pantoprazole
controls Pantoprazole 40mg qd for 28days
干预措施: pantoprazole (Drug)
Pantoprazole + Rebamipde
Pantoprazole 40mg qd + Rebamipide 100mg Tid for 28days
干预措施: Rebamipide (Drug)
Pantoprazole + Rebamipde
Pantoprazole 40mg qd + Rebamipide 100mg Tid for 28days
干预措施: pantoprazole (Drug)
结局指标
主要结局
Healing efficacy of Rebamipide in the treatment of iatrogenic gastric ulcer
时间窗: at 2month after endoscopic submucosal dissection (ESD)
Healing efficacy will be assessed by the change of ulcer size. Quality of Ulcer Healing(QOUH) wil be assessed by nodularity in the healed ulcer by two endoscopist.
次要结局
未报告次要终点
研究者
Shin, Woon Geon
Professor
Kangdong Sacred Heart Hospital