跳至主要内容
临床试验/EUCTR2011-006208-11-ES
EUCTR2011-006208-11-ES进行中(未招募)不适用

A randomized, controlled multicenter clinical trial comparing endoscopic band ligation versus oral carvedilol in the primaryprophylaxis of esophageal variceal bleeding in patients with cirrosis

CAIBER0 个研究点开始时间: 2012年2月28日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • ? Age from 18 to 80 years.
  • ? Liver cirrhosis diagnosed by liver biopsy or unequivocal clinical, analytical or radiologic criteria
  • ? Presence of esophageal varices or gastroesophageal varices type GOV1, medium or large in size (>5 mm)
  • ? Ability to understand study procedures and to comply with them for the entire length of the study.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 290
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 100

排除标准

  • ? Previous esophageal variceal bleeding.
  • ? Pregnant or lactating patients
  • ? Known hypersensibility to carvedilol
  • ? Contraindications to carvedilol.
  • ? Patients already taking beta-blockers
  • ? Previous endoscopic band ligation or endoscopic injection sclerotherapy
  • ? Total portal vein thrombosis or portal vein cavernoma
  • ? Hepatocellular carcinoma out of Milano criteria
  • ? End-stage liver disease as indicated by a Child-Pugh score over 13.
  • ? Extrahepatic malignancy that significantly affects survival
  • ? Previous TIPS or porto-caval shunt

研究者

发起方
CAIBER

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