NCT01836900Unknown不适用
Endoscopic Treatment of Recurrent Upper GI Bleeding From Gastroduodenal Ulcers: OTSC [Over the Scope Clip] Versus Standard Therapy
Kliniken Ludwigsburg-Bietigheim gGmbH2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2013年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Persistent bleeding or Rebleeding with 7 days
研究概览
简要总结
Prospective-randomized trial. Patients with recurrent bleeding from gastroduodenal ulcers are randomized into either endoscopic treatment with the OTSC [Over The Scope Clip] or endoscopic standard therapy. Hypothesis: Endoscopic therapy with OTSC is superior to standard therapy regarding technical success and rebleeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Recurrence of bleeding from gastroduodenal ulcers
排除标准
- •Malignant ulcers, variceal bleeding, patients younger than 18 years, lesions not suitable for treatment with OTSC
结局指标
主要结局
Persistent bleeding or Rebleeding with 7 days
时间窗: 7 days
次要结局
- Amount of endoscopic reinterventions(7 d)
- blood units transfused(30 days)
- duration of hospital stay(30 days)
- duration of intensive care unit stay(30 days)
- 30 d Mortality(30 days)
- Necessity of surgical or angiographic therapy(7 d)
- Complications during or after OTSC (Over The Scope Clip) placement(7 d)
研究者
研究点 (2)
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