EUCTR2011-006208-11-ES
Active, not recruiting
Not Applicable
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 sitesFebruary 28, 2012
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Esophageal variceal bleeding in patients with cirrhosis
- Sponsor
- CAIBER
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •? 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
Exclusion Criteria
- •? 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
Outcomes
Primary Outcomes
Not specified
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