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临床试验/NCT01196481
NCT01196481已完成不适用

A Prospective,Open Labeled, Randomized Controlled Trial Comparing Carvedilol + VSL# 3 Versus Endoscopic Variceal Ligation for Primary Prophylaxis of Esophageal Variceal Bleeding in Cirrhotic Patients Non Responder to Carvedilol.

Institute of Liver and Biliary Sciences, India1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Development of first variceal bleeding

研究概览

简要总结

Patients of cirrhosis will be enrolled who have large esophageal varices, which have never bled. After successful screening baseline hepatic venous pressure gradient (HVPG) will be measured. Tablet carvedilol 3.125 mg BD for 1 week will be started. It will be increased to 6.25 mg BD and continued for next 7 weeks. After completion of 8 weeks the hepatic venous pressure gradient (HVPG) will again be measured to find out responders (hepatic venous pressure gradient ≥20% reduction from baseline or absolute value of hepatic venous pressure gradient <12 mm Hg) and non responders (hepatic venous pressure gradient <20% reduction).The responders will be excluded from the study while the non responders will be randomize into carvedilol+VSL#3 versus Endoscopic Variceal Ligation.

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

  • Patients of cirrhosis with portal hypertension aged 18 to 75 years who have large esophageal varices with or without red color signs and have not bled previously.

排除标准

  • Any contra-indication to beta-blockers
  • Coagulopathy with INR >1.8 at the time of enrollment
  • Any Endoscopic Variceal Ligation or sclerotherapy within last 3 months
  • Any past history of surgery for portal hypertension
  • Significant cardio or pulmonary co-morbidity
  • Any malignancy
  • Refusal to participate in the study

研究组 & 干预措施

Carvedilol+VSL#3

Experimental

Tablet Carvedilol 6.25 mg BD + VSL#3

干预措施: Carvedilol+VSL#3 (Drug)

Endoscopic Variceal Ligation

Active Comparator

Endoscopic Variceal Ligation every 3-4 weeks till variceal ligation

干预措施: Carvedilol+VSL#3 (Drug)

Endoscopic Variceal Ligation

Active Comparator

Endoscopic Variceal Ligation every 3-4 weeks till variceal ligation

干预措施: Endoscopic variceal ligation (Procedure)

结局指标

主要结局

Development of first variceal bleeding

时间窗: 1 Year

次要结局

  • Survival(1 Year)
  • Reduction in Portal pressure(1 Year)
  • Time to bleed(1 Years)
  • Adverse events(1 Year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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