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
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