NCT04499898招募中2 期
Randomized Controlled Trial of Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding in Cirrhotic Patients With Arterial Hypertension
Sherief Abd-Elsalam1 个研究点 分布在 1 个国家目标入组 306 人开始时间: 2018年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 306
- 试验地点
- 1
- 主要终点
- Number of patients with the first variceal bleeding within 1 year
研究概览
简要总结
Carvedilol versus endoscopic band ligation for primary prophylaxis of oesophageal variceal bleeding in cirrhotic patients with arterial hypertension
详细描述
A Randomized controlled trial of carvedilol versus endoscopic band ligation for primary prophylaxis of oesophageal variceal bleeding in cirrhotic patients with arterial hypertension
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Aged >18 years
- •Cirrhotic patients with arterial hypertension
- •Endoscopic evidence of medium/large-sized esophageal varices
排除标准
- •• History of variceal bleeding or previous primary prevention of varices.
- •Portal vein thrombosis or previous porto-systemic shunts as TIPS.
- •Patients on drugs affecting portal pressure (beta blockers, nitrates).
- •Advanced cardiovascular disease including acute myocardial infarction, atrio-ventricular block, congestive heart failure, chronic peripheral ischemia, severe bradycardia.
- •Patients with severe respiratory diseases (COPD, bronchial asthma).
- •Uncontrolled diabetes mellitus
- •Renal impairment
- •Hepatocellular carcinoma
- •Allergy to carvedilol
- •Pregnancy or lactation
研究组 & 干预措施
carvedilol
Experimental
Carvedilol
干预措施: Carvedilol (Drug)
Band Ligation
Active Comparator
Band Ligation
干预措施: Endoscopic band ligation (Procedure)
结局指标
主要结局
Number of patients with the first variceal bleeding within 1 year
时间窗: 1 year
The number of patients with the first variceal bleeding within 1 year
次要结局
未报告次要终点
研究者
Sherief Abd-Elsalam
Ass. Prof. Tropical Medicine
Tanta University
研究点 (1)
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