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

Status: Withdrawn

Conditions: Advanced Cirrhosis

Treatments: Procedure: Endoscopic Variceal Ligation; Other: Placebo; Drug: Non selective beta blocker

Study type: Interventional

Funder types: Other

Identifiers

NCT02739581

ILBS-Cirrhosis-04

Details and patient eligibility

About

The patients will be randomized into two groups

1. Endoscopic Variceal Ligation with Non Selective Beta Blocker
2. Placebo with Endoscopic Variceal Ligation

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

Endoscopic variceal ligation with Non-selective B-blockers

Experimental group

Treatment:

Procedure: Endoscopic Variceal Ligation

Drug: Non selective beta blocker

Endoscopic variceal ligation with Placebo

Active Comparator group

Treatment:

Other: Placebo

Procedure: Endoscopic Variceal Ligation