Randomized Controlled Trial of Hemostatic Powder Versus Optimal Clinical Management for the Treatment of Upper Gastrointestinal Bleeding From Tumor Lesions
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 62
- 主要终点
- rebleeding
研究概览
简要总结
This study evaluates the efficacy of the endoscopic hemostatic powder for the treatment of bleeding from malignant lesions of the upper GI tract. Half of participants will receive hemostatic powder and half will be submitted to standard treatment.
详细描述
Gastrointestinal tumor bleeding is a challenging clinical condition with a high mortality rate. Several endoscopic hemostasis techniques have been tested, but results were disappointing. Re-bleeding and mortality rates are still high.
Hemostatic powder is a promising therapy for tumor bleeding, since it can be applied over large surfaces. Bleeding from a tumor lesion often occurs diffusely on the surface of the tumor rather than from a specific vessel.
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
- Double (Participant, Care Provider)
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
- •Any kind of malignancy
- •Gastrointestinal bleeding in the last 48 hours
- •Referred to emergency endoscopy
排除标准
- •under 18 years old
- •bleeding from non malignant lesions
- •previous endoscopic treatment with another method done in the last 48h
结局指标
主要结局
rebleeding
时间窗: until 30 days after endoscopy
mortality
时间窗: until 30 days after endoscopy
次要结局
- Successful initial hemostasis(From the moment of the procedure until 24 hours after it)
- Hospital length of stay(from the moment of the endoscopic procedure until hospital discharge or death, whichever came first, assessed up to 100 months)
研究者
Fauze Maluf Filho
Professor
Instituto do Cancer do Estado de São Paulo