Efficacy and Safety of Endoscopic Variceal Ligation (EVL) Versus EVL Plus Non-selective B-blockers (NSBB) For Prevention of Variceal Rebleed and Non-bleed Related Complications in Patients With Advanced Cirrhosis

Study Overview
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Brief Summary
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The patients will be randomized into two groups Endoscopic Variceal Ligation with Non Selective Beta Blocker Placebo with Endoscopic Variceal Ligation

Official Title
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Efficacy and Safety of Endoscopic Variceal Ligation (EVL) Versus EVL Plus Non-selective B-blockers (NSBB) For Prevention of Variceal Rebleed and Non-bleed Related Complications in Patients With Advanced Cirrhosis

Conditions
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Advanced Cirrhosis

Intervention / Treatment
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* Procedure: Endoscopic Variceal Ligation
* Drug: Non selective beta blocker
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic variceal ligation with Non-selective B-blockers<br> | Procedure: Endoscopic Variceal Ligation<br> <br> Drug: Non selective beta blocker<br> <br> |
| Active Comparator: Endoscopic variceal ligation with Placebo<br> | Procedure: Endoscopic Variceal Ligation<br> <br> Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of variceal bleeding |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of variceal bleeding |  | 24 months | 
| Survival |  | 12 months | 
| Survival |  | 24 months | 
| Bleeding severity in both arms |  | 12 months | 
| Bleeding severity in both arms |  | 24 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 | 
| Incidence or progression of Portal Hypertension complications such as Hepatorenal syndrome in both arms. |  | 12 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 |