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Clinical Trials/EUCTR2011-006208-11-ES
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.

Registry
who.int
Start Date
February 28, 2012
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
CAIBER

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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