Esophageal variceal bleeding in patients with cirrhosis
Conditions
Interventions
Trade Name: Carvedilol ratiopharm 6,25 mg comprimidos recubiertos con película EFG
Product Name: Carvedilol ratiopharm 6,25 mg comprimidos recubiertos con película EFG
Pharmaceutical Form: Tablet
CAS
Sponsors
CAIBER
Eligibility
Sex/Gender
All
Inclusion 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
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 ? Previous TIPS or porto-caval shunt
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. To evaluate whether carvedilol, as compared to endoscopic band ligation, a) improves survival b) decreases the incidence of variceal bleeding and of bleeding from non-variceal sources c) decreases the development of other complications of portal hypertension (ascites, spontaneous bacterial peritonitis, bacterial infections, hepatorrenal syndrome, and hepatic encephalopathy). 2. To compare the incidence of portal vein thrombosis between both treatment arms. 3. To compare the rate of adverse events. 4. To compare the costs of both treatments.;Main Objective: To evaluate whether carvedilol improves bleeding free survival in patients with cirrhosis and medium or large esophageal varices when compared with endoscopic band ligation.;Primary end point(s): Time to first variceal bleeding or death.;Timepoint(s) of evaluation of this end point: In every follow up visit (V1-V7) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Time to variceal bleeding. 2. Time to death. 3. Time to death or liver transplantation. 4. Incidence of clinical decompensation (development of ascites, spontaneous bacterial peritonitis, bacterial infections, hepatorenal syndrome or hepatic encephalopathy). 5. Incidence of portal vein thrombosis, assessed by abdominal Doppler-ultrasound. 6. Proportion of patients with adverse events. 7. Proportion of patients with severe adverse events. 8. Costs of the Management of the patients.;Timepoint(s) of evaluation of this end point: 1. In every follow up visit (V1-V7) 2. In every follow up visit (V1-V7) 3. In every follow up visit (V1-V7) 4. In every follow up visit (V1-V7) 5. V2-V7 6. V0-V7 7. V0-V7 8. In every follow up visit (V1-V7) | — |
Countries
Spain
Contacts
Public ContactUCICEC ALBACETE
CAIBER
Outcome results
None listed