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.
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
- 否
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
Tablet Carvedilol 6.25 mg BD + VSL#3
干预措施: Carvedilol+VSL#3 (Drug)
Endoscopic Variceal Ligation
Endoscopic Variceal Ligation every 3-4 weeks till variceal ligation
干预措施: Carvedilol+VSL#3 (Drug)
Endoscopic Variceal Ligation
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)
