JPRN-UMIN000013995招募中未知
The efficacy of endoscopic tissue shielding method with polyglycolic acid(PGA) sheets and fibrin glue for the prevention of delayed bleeding after endoscopic submucosal dissection in patients on antiplatelet therapy.-multicenter randomized control study
agasaki University Hospital0 个研究点目标入组 300 人开始时间: 2014年6月1日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional,observational
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) The patients on antiplatelet therapy who will undergo ESD of gastric neoplasms.
- •2) Early gastric cancer based on its absolute indication and extended indication criteria.
- •3) There is no significant metastasis clinically.
- •4) The patients who have given written informed consent to this study, and age at the time of the agreement acquisition is 20 years or older.
- •5) In principle, the antiplatelet agent is low dose aspirin(LDA) only. In the case of the patients who are received multidrug therapy, they are displaceable to LDA only.
排除标准
- •1)Patient who have double cancer
- •(The cancer in situ or intramucosal carcinoma which can be cured completely by endoscopy operation, that is proper.)
- •2)Patient with the following serious complications
- •?severe hepatic dysorder
- •?severe heart disease(myocardial infarction,angina,congestive heart failure)
- •?severe renal dysfunction
- •3)The patient who have severe infection
- •4)Pregnant woman or with the possibility.The woman who is lactation period.
- •5)Severe bleeding or shock state.
- •6)Patients with bleeding tendency.
- •7)Patients who have not passed more than three months after the end or are participating in the another clinical study.
- •8)Those who are considered to be inappropriate for this study by doctors.
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