Variceal bleeding Circulatory System Variceal bleeding
Conditions
Interventions
Control group: nadolol + isosorbide mononitrate for the prevention of rebleeding
Experimental group: nadolol + isosorbide mononitrate + endoscopic banding ligation for the prevention o
Sponsors
Individual Sponsor (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age between 18-75 2. Diagnosis of cirrhosis 3. Hematemesis or melena within 7 days prior to inclusion 4. Esophageal or gastroesophageal varices as the source of bleeding 5. Written informed consent 6. Exclusion of pregnancy in woman of child-bearing potential
Exclusion criteria
Exclusion criteria: 1. Hepatocellular carcinoma >5 cm or multinodular 2.Creatinine >2 mg/dl 3. Child-Pugh =13 points 4. Contraindications to beta-adrenergic blockers 5. Contraindications to ISMN 6. Banding ligation in the 3 months before the present episode of variceal bleeding 7. Previous portosystemic derivative therapy 8. Bleeding from fundal or ectopic varices 9. Total portal vein thrombosis or portal vein cavernomatosis 10. The patient was already on beta-adrenergic blockers and ISMN for the prevention of variceal bleeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rebleeding from any source | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rebleeding from esophageal varices 2. Rebleeding from other portal hypertensive sources 3. Death 4. Death from variceal bleeding 5. Death from rebleeding 6. Frequency of severe adverse events 7. Relation between changes in hepatic venous pressure gradient and clinical events 8. Development of any complication of portal hypertension or death 9. Changes in variceal size 10. Transfusion requirements 11. Requirement for alternative therapies 12. Costs | — |
Countries
Spain
Outcome results
None listed