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

• Status: Withdrawn
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The patients will be randomized into two groups

1. Endoscopic Variceal Ligation with Non Selective Beta Blocker

2. Placebo with Endoscopic Variceal Ligation

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India
• Treatments: Adrenergic beta-Antagonists

Criteria

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