Banding Ligation Plus Propranolol Versus Banding Ligation to Prevent Rebleeding of Esophageal Varices
试验速览
- 阶段
- 4 期
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- recurrent esophageal variceal bleeding
研究概览
简要总结
Esophageal variceal bleeding is a severe complication of portal hypertension. Banding ligation plus non-selective beta-blockers is the current recommendation for prevention of recurrent bleeding. However, the optimal duration of use of non-selective beta-blockers is not well defined. This study aims at comparing the rebleeding rate and adverse effects in patients using or without using propranolol after eradication of esophageal varices.
详细描述
Cirrhotic patients with acute or recent esophageal variceal bleeding undergo banding ligation at 1-month interval until eradication of esophageal varices. Patients start propranolol (start with 30 mg daily) at 6th day after control of acute bleeding till eradication of esophageal varices, aiming at decreasing pulse rate to 25% or to 55 bpm while systolic pressure is above 85 mmHg. Patients randomized to propranolol group continue propranolol after eradication of esophageal varices. Patients randomized to banding ligation group discontinue propranolol after eradication of esophageal varices. Patients are followed to evaluate the incidence of rebleeding, adverse effects and survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 20 to 80 years
- •Cirrhotic patients with acute or recent esophageal variceal bleeding proven by an endoscopy
- •Stable hemodynamic condition for at least 3 days after banding ligation
排除标准
- •Hepatocellular carcinoma or other malignancy
- •Stroke or active sepsis
- •Chronic kidney disease under renal replacement therapy
- •Contraindications to non-selective beta-blockers
- •A history of non-selective beta-blockers use, sclerotherapy, banding ligation, transjugular intrahepatic porto-systemic shunt, or shunt surgery
- •Serum total bilirubin >10 mg/dL
- •Grade III/IV hepatic encephalopathy
- •Refractory ascites
- •Hepato-renal syndrome
- •Pregnancy
- •Severe heart failure (NYHA Fc III/IV)
- •Bronchial asthma or chronic obstructive pulmonary disease
- •Second or third degree atrioventricular block
- •Sick sinus syndrome
- •Pacemaker use
- •Severe hypotension
- •Refusal to participate
研究组 & 干预措施
Propranolol group
Patients randomized to propranolol group continue propranolol after eradication of esophageal varices.
干预措施: propranolol (Drug)
结局指标
主要结局
recurrent esophageal variceal bleeding
时间窗: 6 years
recurrent esophageal variceal bleeding after eradication of esophageal varices
mortality or liver transplantation
时间窗: 6 years
mortality or liver transplantation after eradication of esophageal varices
次要结局
- adverse effects(6 years)
研究者
Wen-Chi Chen
Division of Gastroenterology and Hepatology
Kaohsiung Veterans General Hospital.