Comparative Study of Carvedilol Monotherapy Versus Combination Therapy With Endoscopic Variceal Ligation (EVL) for Primary Prophylaxis of Variceal Bleeding in Patients With Hepatocellular Carcinoma With High-Risk Esophageal Varices

Study population: All patients aged ≥ 18 years and ≤ 80 years admitted in Institute of Liver and Biliary Sciences, New Delhi with HCC of any cause and high risk esophageal varices and are giving written consent for participation in the study.

Study design - Single center, Open label, Randomized controlled trial Study period - 6 months Intervention - The patients will be randomized into Group -A (NSBB arm) and Group-B (EVL + NSBB arm). Both the group will receive the remaining treatment as per protocol Group A: Non-selective beta blocker (Carvedilol 3.125 mg BD for 3 days followed by 6.25 mg BD , maximum dose would be 12.5 mg BD , same shall be switch to maximum tolerable dose if SBP< 90 , H,R<55) Group B: Non-selective beta blocker (Carvedilol 3.125 mg BD for 3 days followed by 6.25 mg BD , maximum dose would be 12.5 mg BD , same shall be switch to maximum tolerable dose if SBP< 90 , H,R<55) + EVL every 3 weeks till eradication of varices followed by every 3 months.

Monitoring and assessment: Monitoring and evaluation would be done once a month for first 3 months then at 6th month.

Inclusion criteria

• Age 18-80 years
• Cirrhosis with HCC
• High risk oesophageal varices (*large or small with RCS)
• Valid consent

Exclusion criteria

• Any contra-indication to beta-blockers
• Any EVL or Sclerotherapy within last 3 months
• Any past history of TIPS or surgery for portal hypertension
• HCC with BCLC-D
• Patients with past history of variceal bleed.
• Patient With Liver transplant expected in next 2 weeks would be excluded