Appropriate Time Interval for Repeat Sessions of Endoscopic Ligation for the Eradication of Esophageal Varices
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Proportion of Patients With Eradication of Esophageal Varices
研究概览
简要总结
Patients with liver disease frequently present to the hospital with bleeding from dilated veins in their foodpipe (called esophageal varices). The current standard of care is to perform endoscopic variceal ligation (placing rubber bands around the varices through an endoscope)in patients presenting with bleeding varices. Patients generally receive ligation at the time they come in with bleeding and then return at regular intervals to have repeat ligation in order to eradicate the varices. However there have been no studies to determine the appropriate intervals for esophageal variceal ligation until eradication. We will conduct a randomized comparison of 1-week vs. 2-week intervals for esophageal ligation in patients that have presented with bleeding varices. Our hypothesis is that one-week ligation will achieve more rapid eradication than the two-week interval with a greater proportion of patients achieving variceal eradication at 4 weeks after the index bleeding episode.
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
- •Patients who presented with acute upper GI bleeding due to esophageal varices and underwent successful endoscopic variceal ligation.
- •Patients who would normally receive repeat endoscopic ligation therapy to eradicate varices.
排除标准
- •Persistent bleeding despite endoscopic and medical therapy
- •Platelet count < 40,000
结局指标
主要结局
Proportion of Patients With Eradication of Esophageal Varices
时间窗: At 4 weeks
次要结局
未报告次要终点
研究者
Loren Laine
Investigator
University of Southern California
