JPRN-UMIN000007170已完成3 期
Multicenter Randomized Controlled Trial to Assess the Necessity of Second-look Endoscopy after Endoscopic Submucosal Dissection (ESD) for gastric neoplasms: the SAFE study - SAFE study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) History of gastrectomy or reconstruction of gastric tube. 2) History of radiation therapy to the upper abdominal region. 3) With a scheduled endoscopic treatment for esophageal lesion or duodenal lesion concurrently. 4) History of endoscopic treatment for upper GI lesion in the past 28 days. 5) With a scheduled endoscopic treatment for upper GI lesion in 28 days after gastric ESD. 6) With an allergy to proton pomp inhibitor. 7) Systemic administration (intravenously or orally) of either one or more drugs of corticosteroid, anticoagulant agent or antiplatelet agent. 8) Systemic administration of non-steroid anti-inflammatory drug which cannot be suspended through 7 days before to 28 days after gastric ESD. 9) Pregnant or lactation woman. 10) Diagnosis of psychosis. 11) With active bacterial or fungus infection. 12) History of myocardial infarction or unstable angina pectoris within 3 months. 13) With uncontrollable hypertension. 14) With severe respiratory disease requiring continuous oxygen therapy.
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