Prophylactic Injection Therapy Reduces Recurrent Bleeding Rate In Forrest Type IIb Duodenal Ulcer Bleeding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Evidence of clinically definitive recurrent bleeding confirmed by upper gastrointestinal system endoscopy or surgery.
研究概览
简要总结
The purpose of this study is to determine whether prophylactic injection therapy reduces recurrent bleeding rate for duodenal ulcers which has the endoscopic stigmata of recent bleeding.
详细描述
The benefit of endoscopic therapy in ulcers with adherent clots on their surface is still uncertain. A prophylactic injection therapy may reduce the recurrent bleeding rate at this group of patients having this endoscopic stigma of recent bleeding. This type of ulcers are named as type IIb duodenal ulcers according to Forrest's classification, They cary the risk of bleeding recurrence up to 36 percent and as it is reported previously there may be a 12 fold increasement in morbidity and mortality in such cases. A prophylactic endoscopic injection therapy may reduce the risk of recurrent bleeding in this group of the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Endoscopic diagnose of Forrest type 2b duodenal ulcer.
排除标准
- •Patients at whom the onset of Upper Gastrointestinal system bleeding symptoms exceeded 24 hours at index endoscopy.
- •Patients having hemodynamic instability: systolic blood pressure below 90 mm/hg, heart rate above 110/min
- •Demonstration of hemoglobin fall more than 2 g/dl in two hours.
- •Patients with coexisting ulcers elsewhere than in duodenum.
- •Patients under anticoagulant therapy other than Aspirin.
结局指标
主要结局
Evidence of clinically definitive recurrent bleeding confirmed by upper gastrointestinal system endoscopy or surgery.
时间窗: within first two days after index endoscopy
次要结局
未报告次要终点