NCT00690027已完成不适用
San Diego Bleeding Esophageal Varices Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 2
- 主要终点
- Survival
研究概览
简要总结
In unselected cirrhotic patients with bleeding esophageal varices to compare the influence on mortality rate, duration of life, quality of life, and economic costs of treatment of:
- Emergency portacaval shunt, and
- Emergency and long-term endoscopic sclerotherapy.
详细描述
See attached Synopsis - APPENDIX 1
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
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with UGI bleeding (blood in the esophagus, stomach, or duodenum) who enter the emergency room or develop bleeding while in the hospital or are transferred from nearby hospitals and are suspected of having cirrhosis and BEV will be eligible for consideration (all comers).
- •Those who are shown to have the findings of cirrhosis and esophageal varices that:
- •Are seen to be actively bleeding;
- •Have an adherent clot;
- •Have no other associated lesion that could reasonably account for bleeding of that magnitude (such as large gastric or duodenal varices, GU, DU, etc)
- •Require 2 or more units of blood transfusion, will be included in the study.
排除标准
- 未提供
结局指标
主要结局
Survival
时间窗: 10 years
次要结局
- Control of bleeding and quality of life(10 years)
研究者
研究点 (2)
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