A randomized phase IV clinical trial comparing Nadolol and Isosorbide Mononitrate (ISMN) with the combination of Endoscopic Banding Ligation plus Nadolol and ISMN in the prevention of variceal rebleeding
- Conditions
- Variceal bleedingCirculatory System
- Registration Number
- ISRCTN26221020
- Lead Sponsor
- Individual Sponsor (Spain)
- Brief Summary
2009 Results article in http://www.ncbi.nlm.nih.gov/pubmed/19218249 pub
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 160
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rebleeding from any source
- Secondary Outcome Measures
Name Time Method <br> 1. Rebleeding from esophageal varices<br> 2. Rebleeding from other portal hypertensive sources<br> 3. Death<br> 4. Death from variceal bleeding<br> 5. Death from rebleeding<br> 6. Frequency of severe adverse events<br> 7. Relation between changes in hepatic venous pressure gradient and clinical events<br> 8. Development of any complication of portal hypertension or death<br> 9. Changes in variceal size<br> 10. Transfusion requirements<br> 11. Requirement for alternative therapies<br> 12. Costs<br>