Endoscopic Treatment of Non-variceal Upper GI-bleeding With High Risk of Recurrency - OTSC (Over-the-scope-clip) Versus Standard Therapy (STING2)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Persistent bleeding or Rebleeding with 7 days
研究概览
简要总结
Prospective-randomized multi-center trial. Patients with high risk of recurrent GI-bleeding (non-variceal) are identified and 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.
详细描述
Prospective-randomized multi-center trial. Patients with high risk of recurrent GI-bleeding (non-variceal) are identified (Rockall Score > 6) and randomized into either endoscopic treatment with the OTSC [Over The Scope Clip] or endoscopic standard therapy. 100 Patients are planned. 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
- 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
- •upper GI-bleeding (non-variceal) with high risk of recurrency
- •18 years and older
排除标准
- •variceal-bleeding
- •under 18 years
- •pregnancy or nursing period
- •malignancy
- •need for surgical treatment (for example perforation with peritonitis)
研究组 & 干预措施
OTSC
Initial treatment with the OTSC for non-variceal upper GI-bleedings with high risk of recurrency.
干预措施: OTSC (Device)
Standard therapy
Endoscopic standard therapy (two techniques e.g. clip and injection)
干预措施: Endoscopic Standard therapy (combining two methods) (Device)
结局指标
主要结局
Persistent bleeding or Rebleeding with 7 days
时间窗: 7 days
次要结局
- blood units transfused(30 days)
- duration of hospital stay(30 days)
- duration of intensive care unit stay(30 days)
- 30 d Mortality(30 days)
- Amount of endoscopic reinterventions(7 days)
- Necessity of surgical or angiographic therapy(7 days)
- Complications during or after OTSC (Over The Scope Clip) placement(7 days)