Study comparing the use of a medical procedure (endoscopic band ligation) versus a drug treatment (carvedilol) to prevent bleeding of esophageal varices in patients with liver disease.
- Conditions
- Esophageal variceal bleeding in patients with cirrhosisTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2011-006208-11-ES
- Lead Sponsor
- CAIBER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
? 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
? 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method