Doppler-guided Endoscopic Treatment in Peptic Ulcer Bleeding
试验速览
- 阶段
- 不适用
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Rebleeding
研究概览
简要总结
The present study is a randomized controlled trial (RCT) that examines if the outcome of peptic ulcer bleeding could be improved by use of doppler-guided endoscopic treatment.
详细描述
This study evaluates if performance of a control endoscopy with doppler-guided endoscopic treatment is associated with an improved outcome in term of lower rate of rebleeding and lower rate of bleeding-related mortality. A potential risk of increased risk of complications (in particular perforation) among patients treated with control endoscopy is also evaluated. Outcomes are prospectively registered based on patient records.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Peptic ulcer bleeding from ulcers classified as Forrest I-IIb
排除标准
- •Severe comorbidity with a remaining life expectancy below 30 days
研究组 & 干预措施
Supplementary doppler-guided endoscopic therapy
干预措施: Supplementary endoscopy with doppler-guided therapy (Device)
Supplementary doppler-guided endoscopic therapy
干预措施: IV. PPI (Drug)
Supplementary doppler-guided endoscopic therapy
干预措施: Endoscopic treatment at primary endoscopy (Other)
control group
干预措施: IV. PPI (Drug)
control group
干预措施: Endoscopic treatment at primary endoscopy (Other)
结局指标
主要结局
Rebleeding
时间窗: 1 week
Number of participants who develop symptoms of rebleeding combined with a significant drop in systolic blood pressure, or B-haemoglobin, or confirmation of stigmata of bleeding at repeat endoscopy/angiography/surgery.
次要结局
- Bleeding-related mortality(1 month)
- Complications to endoscopic therapy(1 month)
研究者
Stig Borbjerg Laursen
MD, PhD
Odense University Hospital