NCT03069339Unknown不适用
Carvedilol, Endoscopic Variceal Ligation or Combination of Both for Prevention of First Variceal Bleed in Child's B & C 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
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Reduction in the incidence of first variceal bleed at 1 year.
研究概览
简要总结
Study Design: Open labeled randomized controlled trial. The study will be conducted on patients attending outpatient or admitted to admitted to Department of Hepatology from January 2017 to December 2018 at ILBS, New Delhi
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver Cirrhotics between 18-70 yrs of age (cirrhosis diagnosed on the basis of clinical, biochemical, fibroscan & imaging.)
- •CTP ≥ 7-15 (Child's B/C)
- •Small esophageal varices with RCS and large esophageal varices (>5 mm)
- •No history of previous bleed
排除标准
- •Malignancy-HCC, PVT
- •MELD >35
- •Contraindications to β blockers.
- •Platelet count < 30,000/mm3
- •Previous endoscopic variceal treatment. (Beyond 21 days)
- •Patients having an indication for TIPS or requiring more than 1 therapeutic ascitic tapping/month
- •Post TIPS, Shunt surgery
- •Acute kidney injury (Sr.Cr>1.5mg/dl)
- •Non cirrhotic portal hypertension
- •Acute on chronic liver failure
研究组 & 干预措施
Carvedilol+EVL
Experimental
干预措施: Carvedilol (Drug)
Carvedilol+EVL
Experimental
干预措施: Endoscopic Variceal Ligation (Procedure)
Carvedilol
Experimental
干预措施: Carvedilol (Drug)
EVL
Active Comparator
干预措施: Endoscopic Variceal Ligation (Procedure)
结局指标
主要结局
Reduction in the incidence of first variceal bleed at 1 year.
时间窗: 1 year
次要结局
- Improvement in Model for End Stage Liver Disease (MELD) score in all the 3 groups(1 year)
- Incidence of Acute Kidney Injury (AKI) in all the 3 groups(1 year)
- Improvement in Child-Turcotte-Pugh (CTP) score in all the 3 groups(1 year)
- Bleed related Survival in all the 3 groups(1 year)
- HVPG response at 1year in all the 3 groups(1 year)
- Incidence of Shock in all the 3 groups(1 year)
- Treatment related side effects in all the 3 groups(1 year)
- Overall and bleed related Survival in all the 3 groups(1 year)
- Incidence of Spontaneous Bacterial Peritonitis (SBP) in all the 3 groups(1 year)
- Incidence of new ascites in all the 3 groups(1 year)
研究者
研究点 (1)
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