The Effect of Proton Pump Inhibitor and Polaprezinc Combination Therapy for Healing of Endoscopic Submucosal Dissection-induced Ulcer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Ulcering healing rate
研究概览
简要总结
Endoscopic submucosal dissection (ESD) is an advanced technique that enables en bloc resection of superficial tumors in the gastrointestinal tract. ESD, however, is a time-consuming procedure that requires a high level of endoscopic skill to achieve a desirable oncologic outcome. Several procedure-related complications may occur after ESD. Especially, iatrogenic ulcer bleeding after ESD can be a concern for both endoscopists and patients. In order to reduce the bleeding rate, proton pump inhibitors (PPIs) are administered after ESD. In addition, ulcer protective agents such as rebamipide can be added to PPIs for accelerating ulcer healing. We aimed to evaluate the efficacy of polaprezinc for healing of iatrogenic ulcer.
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
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age, between 19 and 79
- •Patients with gastric adenoma or early gastric cancer
- •Patients with ECOG-PS 0 or 1
- •Patients with adequate renal function
- •Patients with adequate hepatic function
- •Patients with adequate bone marrow function
排除标准
- •Patients who has taken the medications for ulcer including PPIs, H2 blockers, and mucosal protective agents within 3 months prior to the ESD.
- •Patients who has taken steroid or NSAIDswithin 3 months prior to the ESD.
- •Patients who has undergone gastrostomy
- •Patients with allergy for pantoprazole, polaprezinc, or rebamipide.
- •Pregnant or breast feeding.
研究组 & 干预措施
Rebamipide group
干预措施: Rebamipide (Drug)
Polaprezinc group
干预措施: Polaprezinc (Drug)
结局指标
主要结局
Ulcering healing rate
时间窗: 4 weeks after the ESD
Healing rate of the iatrogenic ulcer according to the type of ulcer protective agents (polaprezinc vs. rebamipide).
次要结局
- Scarring change rate(4 weeks after the ESD)