Combination of Endoscopic Treatment and Carvedilol Versus Carvedilol alone for Primary Prophylaxis of Patients With Hepatocellular Carcinoma and Esophageal Varices- An open-label parallel group randomized control trial

Gastro-oesophageal variceal bleeding, a major complication of portal hypertension (PHTN), is associated with high mortality rates.(1) Liver cirrhosis is the most common cause of PHTN. Hepatocellular carcinoma (HCC) is a life-threatening complication in patients with liver cirrhosis and is associated with increased portal pressures.(2,3) More than 50% of patients with HCC have esophageal varices (EVs) and, nearly half of these patients experience esophageal variceal bleeding (EVB) if primary prevention strategies are not implemented.(4,5) The prognosis of patients with HCC and EVB is extremely poor, with rebleeding rates of 50% and 6-week mortality rate ranging from 26% to 48%, exceeding the rates seen in patients without HCC.(6–8)

Non-selective beta-blockers (NSBBs) and endoscopic band ligation (EBL) prevent variceal bleeding in cirrhosis patients.(9) However, the risk factors for EVB in patients with HCC are different from those in patients with cirrhosis.(10) HCC increases the hepatic venous pressure gradient (HVPG) through arteriovenous shunting within the tumor and changes in hepatic architecture.(2) Tumour thrombosis in the portal vein also contributes to PHTN and increases variceal bleeding.(3,11)Whether NSBBs alone are sufficient to reduce HVPG levels and prevent EVB in patients with HCC is unclear. Hence, this study aims to compare the efficacy and safety of the combination EBL and NSBBs in the primary prevention of EVB in patients with HCC with high-risk esophageal varices.(9)