Effectiveness of Fibrin Glue to Prevent Bleeding in High-risk Patients After Endoscopic Submucosal Dissection in Gastric Neoplasm : A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Bleeding after ESD
研究概览
简要总结
It is a prospective randomized controlled study to look for effectiveness of fibrin glue to prevent bleeding in high-risk patients after endoscopic submucosal dissection in gastric neoplasm.
详细描述
Investigators want to observe the bleeding rate after endoscopic submucosal dissection for gastric tumors in the high-risk group of bleeding (the size of the iatrogenic ulcer is expected to be 40mm or more, or taking aspirin, antiplatelet drugs, and anticoagulants).
After resection and hemostasis with ESD, Fibrin glue (Greenplast Q™) is applied to the iatrogenic ulcer at the end of the procedure, and the control group will not be applied.
After that, observe whether there is a difference in the bleeding rate within 48 hours and 4 weeks.
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
- 19 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG performance status 0-1
- •Patients scheduled to undergo ESD due to gastric tumor (dysplasia, early gastric cancer)
- •Patients who are expected to have an iatrogenic ulcer size of 40mm or more after endoscopic submucosal dissection, or are taking aspirin, antiplatelet drugs, or anticoagulants
- •Patients who show adequate patient compliance and have adequate geographic distance for follow-up observation.
排除标准
- •Patients with sensitivity to cow protein or its derived ingredients
- •Patients who had previously undergone partial gastrectomy
- •Patients with early gastric cancer at the site previously undergoing ESD
- •Patients with clinically significant cardiopulmonary disease
- •Patients with active hepatitis, liver disease that is not well controlled by treatment, or severe liver disorder
- •Patients with severe renal impairment
- •Patients with severe bone marrow dysfunction
- •Patients with severe blood clotting impairment (including hemophilia)
- •Patients with serious neurological or mental illness (e.g. epilepsy or dementia)
- •Patients with reported side effects of contrast media
- •Pregnant and lactating women
- •Patients who have not obtained the informed consent of the patient and guardian
- •Patients who are inadequate for clinical trials as judged by the attending physician
研究组 & 干预措施
Fibrin glue group
Spread Fibrin glue(Greenplast Q™) at iatrogenic ulcer after gastric ESD
干预措施: Human fibrinogen concentrate (Drug)
结局指标
主要结局
Bleeding after ESD
时间窗: 4 weeks
Number of gastrointestinal bleeding events within 4 weeks after the procedure
次要结局
- Early bleeding after ESD(48 hours)
- Delayed bleeding after ESD(from 48 hours to 4 weeks)
研究者
Soo-Jeong Cho
Clinical associate professor
Seoul National University Hospital