The Role of Hypertonic Dextrose Spray as Endoscopic Topical Hemostatic Agent for Acute Non-Variceal Upper Gastrointestinal Bleeding: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Hemostatic success
研究概览
简要总结
This study is conducted to evaluate the effectivity of hypertonic dextrose spray as an endoscopic topical hemostatic agent, compared to conventional agent (adrenaline injection, followed by hemoclip or thermocoagulation), in patients with acute non-variceal upper GI bleeding.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute non-variceal upper gastrointestinal bleeding caused by peptic or duodenal ulcer, polyps, tumors or malignancy
- •Patients consented to study participation
排除标准
- •Patients with thrombocytopenia (thrombocyte count <100.000 cells/ul) and other forms of coagulopathy
研究组 & 干预措施
Control Group
Patients within control group will be given adrenaline 1:20.000 injection, followed by thermocoagulation or hemoclip
干预措施: Adrenaline 1 Mg/mL Solution for Injection (Drug)
Control Group
Patients within control group will be given adrenaline 1:20.000 injection, followed by thermocoagulation or hemoclip
干预措施: argon plasma coagulation (Procedure)
Control Group
Patients within control group will be given adrenaline 1:20.000 injection, followed by thermocoagulation or hemoclip
干预措施: Hemoclip (Procedure)
Dextrose group
Patients within this group will be given adrenaline 1:20.000 injection, followed by dextrose 40% spray
干预措施: Dextrose 40 % in Water (Drug)
Dextrose group
Patients within this group will be given adrenaline 1:20.000 injection, followed by dextrose 40% spray
干预措施: Adrenaline 1 Mg/mL Solution for Injection (Drug)
结局指标
主要结局
Hemostatic success
时间窗: 5 minute
Number of participants whose bleeding stops within five minutes after intervention is given. Outcome is assessed by independent assessor (not the endoscopy operator), who also attend the endoscopy session and could observe whether the bleeding stops.
次要结局
- Re-bleeding(7 days)
研究者
Hasan Maulahela, MD
Head of Gastrointestinal Endoscopy Center FKUI-RSCM
Dr Cipto Mangunkusumo General Hospital