NCT02005809Unknown3 期
Clinical Impact of Second-look Endoscopy After Endoscopic Submucosal Dissection of Gastric Neoplasm
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 268
- 试验地点
- 2
- 主要终点
- Post-ESD bleeding rate according to second look endoscopy
研究概览
简要总结
Gastroenterologists often follow up second look endoscopy after endoscopic submucosal dissection(ESD) of gastric neoplasms because they want to prevent bleeding of procedure sites. But Goto suggested in his retrospective analysis that a second-look endoscopy after endoscopic submucosal dissection for gastric epithelial neoplasm may be unnecessary. So, the investigators try to identify the hypothesis prospectively in this study.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histological confirmed patients(gastric adenoma or adenocarcinoma)
- •performed gastric ESD patients about 24 hours before
排除标准
- •perforation after ESD
- •piecemeal resection of ESD specimen
- •hemostatic agent or proton pump inhibitor users before ESD
- •heparin or antiplatelet agent users
- •Serious concurrent infection or nonmalignant illness that is uncontrolled
- •Psychiatric disorder that would preclude compliance
- •Allergy history to proton pump inhibitor
结局指标
主要结局
Post-ESD bleeding rate according to second look endoscopy
时间窗: Up to 60days
次要结局
- bleeding complication rate according to location of lesion in stomach.(Up to 60days)
- Bleeding rate according to size of resected specimen(Up to 60days)
- Post ESD bleeding rate according to total procedure time of endoscopic submucosal dissection(Up to 60days)
- Post ESD bleeding rate according to bleeding degree during endoscopic submucosal dissection(Up to 60days)
研究者
Park Moo In
Department of internal medicine, Kosin University Gospel Hospital
Kosin University Gospel Hospital
研究点 (2)
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