Banding Ligation With Carvedilol vs. Carvedilol for the Prevention of First Bleeding in Cirrhotics With Moderate Varices
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- patients with first bleeding
研究概览
简要总结
Endoscopic variceal ligation (EVL) and carvedilol have been documented to be effective in prophylaxis of the first bleeding. The efficacy & safety of combining EVL and carvedilol in prophylaxis of the first bleeding is still unknown. This study aims to investigate the value of combination therapy.
详细描述
Combination of EVL and β-blocker has been proven effective in the prevention of variceal rebleeding . However, Our previous study showed that combination of EVL and nadolol do not have enhanced effect in the prophylaxis of 1st variceal bleeding as compared with nadolol alone . One of the drawbacks of EVL is esophageal ulcer. On the other hand ,carvedilol, an anti-α beta-blocker, has been proven to be more effective than propranolol in the reduction of portal pressure. Carvedilol has been proven to be more effective than EVL in the prevention of 1st variceal bleeding. The investigators thus conduct a multicenter trial to evaluate whether combination of EVL and carvedilol could be more effective than carvedilol alone in the prophylaxis of 1st esophageal variceal bleeding . The goal of patients receiving EVL is to reduce variceal size, not variceal obliteration, in anticipation for fewer sessions required for each patient and fewer possibility of esophageal ulcer bleeding.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhosis with esophageal varices are larger than F
- •No history of variceal bleeding.
- •In three months have not implemented preventive esophageal variceal ligation. (4)age 20yrs～75yrs.
排除标准
- •Association with HCC or other cancers .
- •Refractory ascites.
- •Jaundice, bilirubin > 5mg/dl.
- •Encephalopathy.
- •Cr.>3mg/dL.
- •A-V,block bradycardia (PR < 60/mim).
- •Hypotension systolic blood pressure<95/mmHg .
- •Refusal to participate.
- •Carvedilol allergy
- •Second degree-third degree Atrio-ventricular block.
- •Bradycardia.
- •WPWsyndrome
- •Hypotension
- •Psychogenic shock.
- •Asthma. All the patients are randomized based on a random number.
研究组 & 干预措施
EVL + carvedilol
EVL is performed for 2-3 times carvedilol 6.25mg-12.5 mg per day
干预措施: EVL + carvedilol (Procedure)
carvedilol
carvedilol 6.25-12.5 mg per day
干预措施: carvedilol (Drug)
结局指标
主要结局
patients with first bleeding
时间窗: 3 years
the difference of bleeding episode in both groups.
次要结局
- patients with complications and mortality rates(3 years)