Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage: Can it Guide the Use of and Predict Failure of Endoscopic Treatment? A Prospective, Multicenter, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Recurrent bleeding
研究概览
简要总结
The aim of study is to evaluate whether Doppler ultrasound can accurately identify patients who are at risk of recurrent bleeding, who will require endoscopic therapy, and who will fail endoscopic therapy.
详细描述
Bleeding peptic ulcer is a life-threatening emergency. Endoscopic therapy is a proven technique in the acute hemostasis of bleeding ulcers. Currently there is no objective assessment of adequacy of endoscopic therapy. Endoscopic Doppler ultrasound enables endoscopists in detecting blood flow in a vessel beneath an ulcer. A persistent signal after endoscopic therapy predicts recurrent bleeding. The current study proposes to compare assessment of ulcer base using either Doppler ultrasound or endoscopists' interpretation of ulcer floors. The trial design is one of a prospective randomized controlled cross-over study in which patients with severe upper gastrointestinal bleeding and documented peptic ulcers at endoscopy are enrolled.
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
- Single (Participant)
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
- •Clean base ulcer with severe upper GIB (defined as melaena, hematochezia, hematemesis, and/or gross blood in NG lavage), and any one of the following:
- •SBP ≤ 90mmHg; P of ≥110 bpm; or orthostatic changes with SBP drops 20mmHg or P increases 20 bpm; or,
- •Transfusion of 2 or more units of packed red blood cells within 12 hrs of admission; or,
- •A documented HCT drop of at lest 6% from baseline.
- •Endoscopically confirmed bleeding from GU, DU, pyloric ulcer, or anastomotic ulcer
- •Pt can either have primary or secondary acute UGI haemorrhage
排除标准
- •Bleeding site from lesion other than GU, DU, pyloric or anastomotic ulcer
- •there is more than one type of significant bleeding lesion
- •Documented hx of cirrhosis / portal HT
- •ESRF requiring any form of dialysis
- •Expected or persistent (>24hrs) coagulopathy with INR> 1.5
- •Platelet count is under 50000/mm3
- •Aspirin User / Plavix [Clopidogrel] User
- •If the ulcer is neoplastic
- •Cannot obtained consent
- •Age < 18 or is pregnant
- •Severe comorbid of which life expectancy <30 days
结局指标
主要结局
Recurrent bleeding
时间窗: Within 30 days
次要结局
- Length of stay(Within 56 days)
- ICU utilization(Within 56 days)
- Blood Transfusion during hospital(Within 56 days)
- Need for urgent/emergent ulcer surgery for bleeding(Within 56 days)
- Need for angiographic treatment of bleeding(Within 56 days)
- Death(within 56 days)
研究者
James Yun-wong Lau
Professor
Chinese University of Hong Kong