跳至主要内容
临床试验/NCT00409084
NCT00409084终止3 期

Beta Blockers Versus Variceal Band Ligation and Beta Blockers for Primary Prophylaxis of Variceal Bleeding

Virginia Commonwealth University2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2006年12月最近更新:
适应症

试验速览

阶段
3 期
状态
终止
入组人数
2
试验地点
2
主要终点
first variceal bleed

研究概览

简要总结

Patients with scarring of the liver (cirrhosis) and portal hypertension (elevated blood pressure in the liver vasculature) can develop esophageal varices (dilated veins). These have an increased risk of bleeding each year. Current recommendations are to prevent bleeding of medium or large varices (when there is no history of bleeding) by starting a blood pressure lowering agent known as a non-selective beta-blocker. Alternatively, rubber bands can be placed on medium to large varices to prevent bleeding (endoscopic variceal band ligation). Using both therapies at the same time has not been studied. In this study, we hope to determine if the use of combination therapy with endoscopic variceal band ligation and beta blockers is more effective than using beta blockers alone to prevent the first bleeding episode from the varices (dilated veins). The efficacy, ability to tolerate, and cost-effectiveness of these two treatment strategies will be compared.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • cirrhosis
  • medium to large varices

排除标准

  • contraindications to beta blockers
  • refusal to give consent
  • prior history of variceal hemorrhage
  • creatinine > 1.5 mg/dl

结局指标

主要结局

first variceal bleed

时间窗: 2 years

次要结局

  • survival(2 years)
  • liver function(1 year)
  • encephalopathy(1 year)
  • quality of life(1 year)
  • frequency of other complications of cirrhosis(2 years)
  • cost utility(1 year)
  • patient preference(1 year)

研究者

申办方类型
Other

研究点 (2)

Loading locations...

相似试验