NCT00587405已完成2 期
Prospective Randomized Study of Cryotherapy Versus Argon Plasma Coagulation Therapy for Treatment Of Watermelon Stomach
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- the proportion of clinical responders (no overt and hematological evidence of ongoing bleeding) and non-responders
研究概览
简要总结
To see if either method of treatment for Watermelon Stomach shows better results
详细描述
Watermelon stomach (WS) is endoscopically recognized by characteristic stripes of angioectasias involving primarily the antrum, and causes transfusion-dependent anemia in the majority of patients. Current endoscopic treatment options, including argon plasma coagulation (APC) Endoscopic cryotherapy is a novel technique that has the potential to safely and more effectively treat WS by virtue of its mechanism of injury and mode of application.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed WS at endoscopy that is associated with significant anemia (Hb < 10 g/dl) and/or overt bleeding (melena, hematochezia or hematemesis) and/or blood transfusions within the past 6 months
- •Able to give informed consent
- •Age > 18 years
排除标准
- •Endoscopic or histological findings inconsistent with WS
- •Known coagulopathy (INR > 2), severe thrombocytopenia (platelet count < 50,000), or bleeding diathesis
- •Endoscopic treatment of WS within the past month
- •Unable or unwilling to give informed consent.
结局指标
主要结局
the proportion of clinical responders (no overt and hematological evidence of ongoing bleeding) and non-responders
时间窗: 6 months
次要结局
- Endoscopic response will constitute the secondary outcome(6 months)
研究者
Louis-Michel Wong Kee Song
Principal Investigator
Mayo Clinic
研究点 (2)
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