Role of Hemostatic Powder (Endo-clotTM) in Success and Prevention of Bleeding Within Gastric Cancer Patients With Bleeding
试验速览
- 阶段
- 2 期
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Rebleeding rate
研究概览
简要总结
Gastrointestinal(GI) hemorrhage related with gastric cancer is prevalent in advanced cases mostly. As endoscopic hemostatic methods such as argon plasma ablation (APC) had developed, controlling GI hemorrhage in gastric cancer is much easier these days. but re-bleeding rate is still high, even after successful hemostasis with APC or electrical coagulation. Furthermore patients who were experienced re-bleeding are expected poorer survival outcomes than those who are not. So excellent bleeding control in gastric cancer is most important in GI hemorrhage of gastric cancer.
Recently developed hemostatic powder [Endo-Clot(TM)] is easy to use and have proven its usefulness in GI hemorrhage in peptic ulcer diseases. So in this study, investigator will try to find out feasibility & safety of Endo-Clot(TM) in GI hemorrhage in gastric cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 19 and less 80 yeas old
- •Gastric cancer was diagnosed with biopsy and/or computed tomography
- •Endoscopic hemostasis is needed upto GI hemorrhage
- •Endoscopic examination is available in 24hours
- •ECOG performance status(PS) <2
排除标准
- •Double primary caner
- •Hypersensitivity of hemostatic power[Endo-Clot(TM)]
- •Variceal bleeding or benign gastric ulcer bleeding
- •Hemodynamically unstable with low systolic BP<90mmHg and/or tachycardia PR>120bpm
- •endoscopic hemostasis within 7 days before screening
- •Contraindication for endoscopic examination
- •Breast feeding
- •bleeding tendency with low platelet count <50,000 /mm^3 and/or INR>2
- •Bacterial infection with needs for antibiotics therapy
- •Unavailable to discontinue anti-coagulation agent for 3days
- •Vascular shunt
- •Cardiovascular and/or pulmonary diseases
- •Active hepatitis or severe liver diseases
- •Renal dysfunction
- •Bone marrow dysfunction
- •Neurologic deficit and/or psychotic feature
- •Unavailable informed consent
研究组 & 干预措施
Endo-Clot(TM)
干预措施: Endo-Clot(TM) (Drug)
结局指标
主要结局
Rebleeding rate
时间窗: within 30 days
Proportion of patients who are experience rebleeding events after hemostasis within 30 days expected to be lower than 10 %. Definition rebleeding events 1. Overt symptoms of GI bleeding(such as hematemesis, melena) and/or Hemoglobin down more than 2g/dl compared to Hemoglobin level which were checked just after procedure.
次要结局
- Success of bleeding control rate(within 2 weeks and 4 weeks)
- Rebleeding rate(in 3 days)
- Rate of additional intervention other than initial endoscopic hemostasis(within 2 weeks to 4 weeks)
- Mortalities(within 2 weeks to 4 weeks)