Supplementary Angiographic Embolization for Peptic Ulcer Bleeding: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Composite Endpoint
研究概览
简要总结
Peptic ulcer bleeding is a common disorder. Despite optimal endoscopic and medical treatment, there is a high risk of rebleeding and high mortality. In this study the investigators examine whether combined endoscopic haemostasis and angiographic embolization resolves in a better outcome than the traditional use of endoscopic haemostasis alone. The study is a randomised controlled trail.
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
- •Clinical signs of upper GI-bleeding
- •Endoscopic verified high-risk ulcer (Forrest I-IIb)
- •Primary haemostasis achieved
排除标准
- •Expected lifetime < 1 month
- •Upper GI-cancer found at endoscopy
研究组 & 干预措施
Intervention group
Patients in this group are treated with usual therapeutic endoscopy including endoscopic combination therapy and 72 hours intravenous proton pump inhibitor. Within 24 hours from the therapeutic endoscopy they receive supplementary angiographic embolization.
干预措施: Angiographic embolization (Procedure)
Control group
Patients in this arm receive standard treatment including therapeutic endoscopy with endoscopic combination therapy followed by 72 hours intravenous proton pump inhibitor.
干预措施: Therapeutic endoscopy (Procedure)
结局指标
主要结局
Composite Endpoint
时间窗: Meassured after a week from primary therapeutic endoscopy
Patients are classified into groups depending on the worst outcome: 1. No clinical signs of rebleeding and requirement of two or less blood transfusions after circulatory stabilization and obtained hemoglobin \> 5,9mmol/L. 2. No clinical signs of rebleeding and requirement of more than two blood transfusions after circulatory stabilization and obtained hemoglobin \> 5,9mmol/L. 3. Rebleeding and achieved secondary haemostasis by endoscopy or angiographic embolization. 4. Rebleeding requiring surgery. 5. Patients who have died. Results are compared using the Wilcoxon rank sum test.
次要结局
- Mortality(1 month)
- Rebleeding(1 month)
- Blood transfusion(1 month)
- Surgical haemostasis(1 month)
- Endoscopic/other haemostatic retreatment(1 month)
- Duration of hospitalization(Estimated 4 days)
- Thromboembolic complications(1 month)
研究者
Stig Borbjerg Laursen
MD
Odense University Hospital