NCT00772057已完成不适用
Early Primary Prophylaxis With Beta-Blockers In Prevention Of Growth Of Small Esophageal Varices In Cirrhosis: A Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- The primary endpoint of the study was the development of large (>5 mm) esophageal varices (grade 3 or 4 by Conn's classification)
研究概览
简要总结
Background and Aims: The efficacy of portal pressure reduction by beta blockers for the management of small (≤5 mm) esophageal varices in patients of cirrhosis is not clear. The present randomized controlled trial aims to address these issues. The investigators also assessed the utility of serial HVPG measurements in these patients.
Patients and Methods: Consecutive patients with cirrhosis with small varices, with no history of variceal bleed, were randomized to receive propranolol or placebo. These patients were further randomized to undergo no HVPG, only baseline HVPG, or serial HVPG measurement. Propranolol was titrated to reduce heart-rate to 55/min.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical, radiological or histologic diagnosis of cirrhosis was made
- •Age was between 18 and 70 years
- •Esophageal varices were small (i.e. ≤5 mm or of grade 1 or 2 according to Conn et al).
排除标准
- •Presence of previous variceal bleeding
- •Previous medical, surgical or endoscopic treatment for portal hypertension
- •Child-Pugh score >13
- •Neoplastic disease of any site
- •Splenic or portal vein thrombosis
- •Concurrent illnesses expected to decrease life expectancy to less than one year
- •Pregnancy
- •Contraindication to beta-blockers (atrioventricular block, sinus bradycardia with heart rate <50 beats per minute, arterial hypotension with systolic blood pressure <90 mm Hg, heart failure, asthma, peripheral arterial disease, or diabetes needing insulin treatment)
- •Concurrent anti-viral treatment during the study period
- •Inability to perform follow-up
- •Failure to give consent to participate in the study.
研究组 & 干预措施
Propranolol group
Active Comparator
干预措施: Propranolol (Drug)
Placebo group
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The primary endpoint of the study was the development of large (>5 mm) esophageal varices (grade 3 or 4 by Conn's classification)
时间窗: 24 months
次要结局
- Secondary endpoints were variceal bleeding, death, adverse effects of beta blockers, and hemodynamic response to beta-blocker in patients who underwent serial HVPG(24 months)
研究者
研究点 (1)
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