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

Institute of Liver and Biliary Sciences, India

Overview

The patients will be randomized into two groups 1. Endoscopic Variceal Ligation with Non Selective Beta Blocker 2. Placebo with Endoscopic Variceal Ligation

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Conditions

Advanced Cirrhosis

Interventions

Endoscopic Variceal LigationPROCEDURE

Non selective beta blockerDRUG

PlaceboOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Outcomes

Primary Outcomes

Recurrence of variceal bleeding

Time frame: 12 months

Secondary Outcomes

Recurrence of variceal bleeding

Time frame: 24 months

Survival

Time frame: 12 months

Survival

Time frame: 24 months

Bleeding severity in both arms

Time frame: 12 months

Bleeding severity in both arms

Time frame: 24 months

Incidence or progression of Portal Hypertension complications such as ascites control in both arms.

Time frame: 12 months

Incidence or progression of Portal Hypertension complications such as Spontaneous Bacterial Peritonitis in both arms.

Time frame: 12 months

Incidence or progression of Portal Hypertension complications such as Hepatorenal syndrome in both arms.

Time frame: 12 months

Appearance or progression of Portal Vein Thrombosis in both arms

Time frame: 12 months

Number of patients receive alternative treatments transhepatic intrajugular portosystemic shunt in both arms.

Time frame: 12 months

Incidence of adverse events in both groups

Data from ClinicalTrials.gov

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