A Randomized, Controlled Trial of Ligation Plus Nadolol Versus Nadolol Alone in the Prophylaxis of First Variceal Bleeding in Cirrhosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 主要终点
- The primary end points of the study were the first episode of variceal bleeding.
研究概览
简要总结
The value of banding ligation plus beta blocker in the prophylaxis of first episodes of variceal bleeding has not yet been evaluated. This study was conducted to compare the efficacy and safety of banding ligation plus nadolol versus nadolol in the prophylaxis of first bleeding in cirrhotic patients with high-risk esophageal varices.
详细描述
Currently, endoscopic variceal ligation (EVL) has replaced EIS as the endoscopic treatment of choice for management of bleeding esophageal varices. The advantages of EVL include requiring fewer treatment sessions to achieve variceal obliteration, lower rebleeding rates and fewer complications (5-9). Controlled studies that compared EVL with beta-blocker in the prevention of first variceal bleeding suggested that EVL was at least equal to beta-blockers in the prophylaxis of first variceal bleeding. However, portal pressure may be elevated after repeated EVL. Hence the combination of nadolol and EVL is a reasonable approach to prevent the first episode of variceal 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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the cause of portal hypertension was cirrhosis
- •the degree of esophageal varices was F2 (moderate varices) or more, associated with any of red color signs (red wale markings, cherry red spots or hematocystic spots)
- •no history of hemorrhage from esophageal varices
- •no current treatment with beta-blockers
- •cirrhosis was based on results of liver biopsy, or clinical and biochemical examinations and image studies
排除标准
- •age greater than 75 years old or younger than 20 years old
- •association with malignancy, uremia or other serious medical illness which may reduce the life expectancy
- •presence of refractory ascites, hepatic encephalopathy or marked jaundice (serum bilirubin > 10 mg/dl)
- •history of shunt operation, transjugular intrahepatic portosystemic stent shunt or endoscopic therapy (EIS or EVL)
- •had contraindications to beta-blockers, such as asthma, heart failure, complete atrioventricular block, hypotension ( systolic blood pressure < 90 mmHg), pulse rate < 60/ min
- •unable to cooperate
研究组 & 干预措施
Ligation+Nadolol
Multi-ligators were applied. Patients received regular ligation treatment at an interval of 3-4 weeks until variceal obliteration.
Intervention; ligation of varices plus beta blockers (Nadolol).
干预措施: Ligation of varices (Procedure)
Ligation+Nadolol
Multi-ligators were applied. Patients received regular ligation treatment at an interval of 3-4 weeks until variceal obliteration.
Intervention; ligation of varices plus beta blockers (Nadolol).
干预措施: Nadolol (Drug)
Nadolol only
干预措施: Nadolol (Drug)
结局指标
主要结局
The primary end points of the study were the first episode of variceal bleeding.
时间窗: 2 years
次要结局
- The secondary end points were adverse events related to treatment and death of any cause.(2 years)