RCT Comparing the Efficacies of Endoscopic Variceal Ligation (EBL) and Combined Treatment of Beta-blocker and EBL for the Prevention of Esophageal Variceal Rebleeding
试验速览
- 阶段
- 4 期
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Rebleeding from esophageal varices
研究概览
简要总结
Both propranolol and endoscopic band ligation (EBL) are effective for prevention of variceal rebleeding. Recently several studies compared the efficacy of EBL alone and with a combination of propranolol and EBL. However, the results of recent studies showed discrepancy. This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients without previous history of endoscopic variceal treatment.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •liver cirrhosis
- •age between 18 and 70 years
- •Successful control of esophageal variceal bleeding within 6 weeks before enrollment
排除标准
- •Gastric variceal bleeding
- •Patients with systolic blood pressure <100 mmHg or basal heart rate <60/min
- •Portal vein thrombosis
- •Prominent hepatic encephalopathy
- •Coexisting untreated malignancy
- •Severe cerebrovascular or cardiovascular disease, renal failure
- •Previous history of endoscopic, radiologic, or surgical treatment for varices or ascites
- •Contraindication to beta-blocker
- •Pregnancy
- •Refusal to give consent to participate in the trial
研究组 & 干预措施
Endoscopic band ligation
Perform endoscopic band ligation (EBL) until esophageal varices are eradicated, and then follow-up endoscopy with 3-6 months interval
干预措施: endoscopic band ligation (Procedure)
EBL+Propranolol
Perform EBL same as EBL group. In addition, take propranolol to reduce 25% in HR or HR ≤55/min
干预措施: EBL+Propranolol (Procedure)
结局指标
主要结局
Rebleeding from esophageal varices
时间窗: 2 years
Rebleeding from esophageal varices
次要结局
- Upper gastrointestinal bleeding; significant esophageal variceal bleeding; mortality;adverse events(2 years)