Randomized Comparison of Trans-catheter Arterial Embolization (TAE) and Surgery in Patients With Major Peptic Ulcer Bleeding Uncontrolled by Endoscopic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Mortality within 30 days of randomization
研究概览
简要总结
The aim of the study is to compare the outcomes of trans-catheter arterial embolization (TAE) and surgery as salvage therapy of peptic ulcer bleeding after failed endoscopic therapy.
详细描述
The aim of the study is to examine the hypothesis that trans-catheter arterial embolization (TAE) is safer than and probably as effective as surgery in the control of bleeding from ulcers after failed endoscopic therapy. Patients with major arterial bleeding that cannot be stopped by endoscopic therapy will be randomly assigned to receive immediate TAE or surgery. Primary outcome will be death within 30 days of randomization. Secondary outcomes include recurrent bleeding after assigned treatment, need for additional intervention either in the form of interventional radiology or surgery, and post procedural morbidities.
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 bleeding peptic ulcers documented during endoscopic therapy AND anyone of the following:
- •Forrest I bleeding that fails to be controlled by therapy during first endoscopy
- •Check endoscopy after clinical re-bleeding of Forrest I bleeding
- •Forrest IIa or an initial IIb but a sizable artery unveiled upon clot elevation in a high risk ulcer defined by:
- •posterior bulbar duodenal ulcer > 2cm, or
- •an angular notch / lesser curve gastric ulcer > 5cm that fail an attempt at endoscopic therapy together with evidence of a significant bleed (hypotension with SBP < 90mmHg, fresh hematemesis or hematochezia).
排除标准
- •Refusal to participate in trial
- •No consent
- •Age < 18
- •Pregnancy
- •Moribund patients
- •Patients with terminal malignancy
结局指标
主要结局
Mortality within 30 days of randomization
时间窗: 30 days
Mortality within 30 days of randomization
次要结局
- Recurrent bleeding after assigned treatment(60 days)
- The need for additional intervention either in the form of interventional radiology(60 days)
- Post procedural morbidities(60 days)
- The need for additional intervention either in the form of surgery(60 days)
研究者
James Yun-wong Lau
Professor
Chinese University of Hong Kong