Hemostatic Powder Following Injection Therapy Versus Conventional Dual Therapy for Endoscopic Hemostasis for Non-variceal Upper Gastrointestinal Bleeding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- The rate of successful initial hemostasis
研究概览
简要总结
Acute upper gastrointestinal hemorrhage (UGIH) is a common condition that leads to hospital admission, and has significant associated morbidity and mortality, especially in the elderly. The most common causes of acute UGIH are nonvariceal. Although up 70% of non-variceal bleeds settle with conservative measures, endoscopic therapy is the established method for treating those bleeds for which this is not sufficient. Despite advances and increased expertise in managing upper gastrointestinal bleeding, the associated mortality of up to 15% has remained unchanged for several years.
EndoClot is a novel topical hemostatic powder approved for use in non-variceal upper gastrointestinal bleeding. This study examines its efficacy for endoscopic hemostasis in non-variceal upper gastrointestinal bleeding. This is a multicenter, prospective, randomized study.
详细描述
Patients with upper GI bleeding who need endoscopic hemostasis will be enrolled in this study. When there is a upper GI bleeding with active bleeding or stigmata on the lesions, endoscopic hemostasis will be done.
After randomization, patients in both group will undergo endoscopic hemostasis with epinephrine injection therapy. In the study group, Endo-clot will be applied after epinephrine injection therapy. In the control group, hemoclip will be applied after epinephrine injection therapy. The efficacy of Endo-Clot and hemoclip will be compared.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 19 years old
- •Patients with hematemesis, hematochezia, melena, suspected upper gastrointestinal bleeding
- •Inpatients who were consulted gastroenterologist for management of upper gastrointestinal bleeding
- •Patients who are planned to undergo EGD for management of upper gastrointestinal bleeding
排除标准
- •Patients who had diagnosed esophageal cancer or stomach cancer
- •Patients who are suspected variceal bleeding, had medical history of liver cirrhosis, hepatocellular carcinoma
- •Coagulation disorder (hemophilia, ITP,,)
- •Post-procedure bleeding (EGD biopsy, EMR, ESD, stent insertion..)
- •Patients who cannot undergo EGD because of anatomical problem, unconsciousness.
- •Patients who are unwilling or unable to provide informed consent, such as those with psychiatric problem, drug abuse or alcoholism
研究组 & 干预措施
Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) group
The intervention group
干预措施: Endo-Clot (Device)
Hemoclip (HX-610-135, Olympus, Japan) or electrical coagulation group
Patients in the control group will undergo endoscopic hemostasis with combination therapy, epinephrine injection therapy and hemoclip or electrical coagulation therapy.
干预措施: hemoclip or electrical coagulation (Device)
结局指标
主要结局
The rate of successful initial hemostasis
时间窗: 5 minites after appilication of Endo-Clot
The primary endpoint was immediate hemostasis which defined as endoscopic observation of bleeding cessation for 5 minutes after appilication of Endo-Clot.
次要结局
- Rebleeding rates(0~14 days after initial endoscopic hemostasis)