Randomized Controlled Trial Comparing Propranolol, Endoscopic Banding Ligation, and Combined Treatment to Prevent First Variceal Hemorrhage in Patients With Liver Cirrhosis
试验速览
- 阶段
- 4 期
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- First esophageal variceal bleeding
研究概览
简要总结
This study is performed to compare the efficacy and safety of EBL, propranolol, and EBL combined with propranolol in patients with medium or large varices.
详细描述
Current guidelines recommend prophylactic treatment with propranolol or endoscopic band ligation (EBL) to prevent variceal bleeding in patients with medium or large varices. However, it is unclear which treatment is more useful in regard to prevention of variceal bleeding as well as safety. In addition, the efficacy and safety of the combination of EBL and propranolol is not still defined. This study is performed to compare the efficacy and safety of EBL, propranolol, and EBL combined with propranolol in patients with medium or large varices.
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
- •Esophageal varices with high bleeding risk: more than F2 and red color sign
- •No previous history of upper gastrointestinal bleeding
- •No previous history of endoscopic, radiologic, or surgical therapy for varices or ascites
- •Do not take beta-blocker, ACE inhibitor, or nitrate
- •Child-Pugh score <12
排除标准
- •Patients with systolic blood pressure <100 mmHg or basal heart rate <60/min
- •Portal vein thrombosis
- •Uncontrolled ascites or hepatic encephalopathy
- •Severe coagulation disorder: prothrombin time <40% (or INR >1.7) or platelet count <30,000/mm3
- •Medium or large sized gastric or duodenal varices
- •Coexisting malignancy
- •Severe cardiovascular disorder, renal failure, peritonitis, sepsis
- •Severe erosive esophagitis, severe esophageal stricture, active gastric or duodenal ulcer
- •Contraindication to beta-blocker
- •Pregnancy
- •Refusal to give consent to participate in the trial
研究组 & 干预措施
Endoscopic band ligation
Endoscopic band ligation until eradication of esophageal varices with 4 weeks interval, and then follow-up endoscopy with 3-6 months interval until 36 months after enrollment
干预措施: Endoscopic band ligation (Procedure)
Propranolol
start with 20 mg b.i.d, and adjust by 20-40 mg/d reaching reduction by 25% in HR or HR ≤55/min. After reaching target HR, then follow-up according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months)
干预措施: Propranolol (Drug)
EBL+Propranolol
- EBL until eradication of esophageal varices with 4 weeks interval, and then follow-up endoscopy with 3-6 months interval until 36 months after enrollment
- start with 20 mg of propranolol b.i.d, and adjust by 20-40 mg/d reaching reduction by 25% in HR or HR ≤55/min. After reaching target HR, then follow-up according to a preset schedule (at 1, 2, 3 months after initial treatment, then every 3 months until 36 months)
干预措施: EBL+Propranolol (Procedure)
结局指标
主要结局
First esophageal variceal bleeding
时间窗: 3 years after enrollment
First esophageal variceal bleeding after enrollment
次要结局
- Mortality; Significant esophageal variceal bleeding; Upper gastrointestinal bleeding except esophageal bleeding; Adverse events(3 years after enrollment)