NCT02739581撤回不适用
Efficacy and Safety of Endoscopic Variceal Ligation (EVL) Versus EVL Plus Non-selective B-blockers (NSBB) For Prevention of Variceal Rebleed and Non-bleed Related Complications in Patients With Advanced Cirrhosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Recurrence of variceal bleeding
研究概览
简要总结
The patients will be randomized into two groups
- Endoscopic Variceal Ligation with Non Selective Beta Blocker
- Placebo with Endoscopic Variceal Ligation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 80 years old.
- •Clinical criteria and/or analytical, ultrasound and/or liver biopsy consistent with the diagnosis of liver cirrhosis.
- •Endoscopic Diagnosis of esophageal variceal bleeding within 5 days prior to study inclusion.
- •Written informed consent to participate in the study.
- •Child C status, CTP >10
排除标准
- •Pregnancy or lactation
- •Serum Creatinine > 2 mg/dl
- •Bleeding due to gastric varices.
- •Active infection or recent infection < 2 weeks
- •Presence of hepatocellular carcinoma or portal vein thrombosis
- •Active alcoholism
- •Pregnancy
- •HIV infection
- •Severe heart, respiratory or contraindications for beta blockers(severe chronic obstructive pulmonary disease, severe asthma, severe insulin-dependent diabetes mellitus, Brady arrhythmia)
- •Not giving consent
研究组 & 干预措施
Endoscopic variceal ligation with Non-selective B-blockers
Experimental
干预措施: Endoscopic Variceal Ligation (Procedure)
Endoscopic variceal ligation with Non-selective B-blockers
Experimental
干预措施: Non selective beta blocker (Drug)
Endoscopic variceal ligation with Placebo
Active Comparator
干预措施: Endoscopic Variceal Ligation (Procedure)
Endoscopic variceal ligation with Placebo
Active Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Recurrence of variceal bleeding
时间窗: 12 months
次要结局
- Survival(24 months)
- Incidence or progression of Portal Hypertension complications such as ascites control in both arms.(12 months)
- Incidence or progression of Portal Hypertension complications such as Hepatorenal syndrome in both arms.(12 months)
- Incidence of adverse events in both groups(12 months)
- Recurrence of variceal bleeding(24 months)
- Bleeding severity in both arms(24 months)
- Incidence or progression of Portal Hypertension complications such as Spontaneous Bacterial Peritonitis in both arms.(12 months)
- Appearance or progression of Portal Vein Thrombosis in both arms(12 months)
- Number of patients receive alternative treatments transhepatic intrajugular portosystemic shunt in both arms.(12 months)
研究者
研究点 (1)
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