Role of Hemostatic Powder (Endo-clotTM) in Prevention of Bleeding Within High Risk Patients After ESD
SD has become a standard treatment of gastric neoplasm confined to mucosa(epithelium). But after procedure, formation of iatrogenic gastric ulcer is inevitable. And Post ESD ulcer bleeding rate reported about 5% ~ 10% of all cases. Antiplatelet or anti-coagulation treatment might be associated higher incidence of rebleeding after ESD and iatrogenic ulcer bigger than 40mm in size is also associated.
Though several previous study have failed to show efficacy of 2nd look EGD, but those reports pointed out that visible vessels with current bleeding or highly suspect of recent bleeding (Forrest type IA~IIB) was observed about 10~20% of patients. Such patients are at high risk of bleeding.
So, Investigators hypothesize that appliance of Endo-Clot(TM) at post ESD ulcer have a significant role of protection from gastric acidic juice and help mucosa heal earlier. Thus visible vessels with risk of bleeding is going to be rarely observed at 2nd look EGD. And finally this protective effect might have an effect for prophylaxis of post ESD ulcer bleeding.
研究概览
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Seoul、大韩民国、03722
- Yonsei university of medical center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
A. Older than 19 years old and younger than 80 years old B. Pathologically confirmed gastric adenoma and/or early gastric cancer C. Iatrogenic gastric ulcer after ESD(Endoscopic submucosal dissection) more than 40mm (at prediction) D. Patients who is taking medication such at aspirin and/or coumadin (and other anti-coagulation medication) E. ECOG performance status 0 or 1 F. Adequate renal function (serum creatinine < 1.5 mg/dL or calculated creatinine clearance ≥ 60 ml/min) G. Adequate liver function (total bilirubin < 1.5 X the upper limits of normal (ULN), AST and ALT <3 X UNL, and alkaline phosphatases < 3 X ULN or < 5 x ULN in case of liver involvement) H. Adequate BM function (WBC ≥ 3,500/µl, absolute neutrophil cell count ≥ 1,500 /µl, platelet count ≥ 100,000/µl) I. Subjects who given written informed consent after being given a full description of the study
Exclusion Criteria:
A. Previously treated by radical gastrectomy B. Adverse effect on this medication C. Pregnant or on breast feeding D. Patients who are unwilling or unable to provide informed consent, such as those with psychiatric problem, drug abuse or alcoholism
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Endo-Clot(TM)
The intervention group
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After patients treated with ESD, Hemostatic power was applied on the post-resection surface by Endo-Clot™ system.
And treated with proton pump inhibitor as usual.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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the bleeding rate until 4 weeks after ESD
大体时间：POD ~ 4 weeks
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Post-ESD bleeding was defined by clinical symptoms or laboratory findings.
Clinical symptoms such as melena or hematemesis were defined as bleeding signs.
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POD ~ 4 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Forrest classification of the post-resection ulcer at 48 hours after ESD
大体时间：POD 2
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On POD 2, patients underwent scheduled second-look endoscopy 48 hours after ESD.
The artificial ulcer induced by ESD was evaluated and classified according to the Forrest classification.
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POD 2
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the bleeding rates according to timing and subgroup
大体时间：POD 0 ~ 4 weeks
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the bleeding rate until 4 weeks after ESD: Post-ESD bleeding was defined by clinical symptoms or laboratory findings.
Clinical symptoms such as melena or hematemesis were defined as bleeding signs.
(Acute bleeding: within 48 hours after ESD & Delayed bleeding: beyond 48 hours after ESD)
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POD 0 ~ 4 weeks
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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关键字
其他研究编号
- 4-2015-0925
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