Advanced Cirrhosis
Conditions
Brief summary
The patients will be randomized into two groups 1. Endoscopic Variceal Ligation with Non Selective Beta Blocker 2. Placebo with Endoscopic Variceal Ligation
Interventions
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients between 18 and 80 years old. * Clinical criteria and/or analytical, ultrasound and/or liver biopsy consistent with the diagnosis of liver cirrhosis. * Endoscopic Diagnosis of esophageal variceal bleeding within 5 days prior to study inclusion. * Written informed consent to participate in the study. * Child C status, CTP \>10
Exclusion criteria
* Pregnancy or lactation * Serum Creatinine \> 2 mg/dl * Bleeding due to gastric varices. * Active infection or recent infection \< 2 weeks * Presence of hepatocellular carcinoma or portal vein thrombosis * Active alcoholism * Pregnancy * HIV infection * Severe heart, respiratory or contraindications for beta blockers(severe chronic obstructive pulmonary disease, severe asthma, severe insulin-dependent diabetes mellitus, Brady arrhythmia) * Not giving consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence of variceal bleeding | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Survival | 12 months |
| Bleeding severity in both arms | 12 months |
| Incidence or progression of Portal Hypertension complications such as ascites control in both arms. | 12 months |
| Incidence or progression of Portal Hypertension complications such as Spontaneous Bacterial Peritonitis in both arms. | 12 months |
| Recurrence of variceal bleeding | 24 months |
| Appearance or progression of Portal Vein Thrombosis in both arms | 12 months |
| Number of patients receive alternative treatments transhepatic intrajugular portosystemic shunt in both arms. | 12 months |
| Incidence of adverse events in both groups | 12 months |
| Incidence or progression of Portal Hypertension complications such as Hepatorenal syndrome in both arms. | 12 months |
Countries
India
Outcome results
None listed