Propranolol plus endoscopic band ligation versus banding alone for secondary prevention of variceal bleeding in hepatocellular carcinoma: a randomised trial

Background and aims Combination therapy with endoscopic band ligation (EBL) and propranolol (PPL) is the standard approach for secondary prevention of oesophageal variceal bleeding (EVB) in patients with liver cirrhosis. However, robust evidence supporting this combination in patients with hepatocellular carcinoma (HCC) is lacking. This randomised controlled study aims to compare EBL alone with combination therapy for secondary prophylaxis of EVB in patients with HCC. Methods This two-centre study enrolled 109 patients with HCC and acute EVB between December 2009 and May 2021. Patients were randomised to receive EBL alone (group A) or EBL combined with PPL (group B). The primary end point was recurrent EVB. Results In this study, 55 patients were randomised to group A and 54 patients to group B. Most patients had hepatitis B virus-related HCC (58.7%), decompensated liver function (Child-Pugh class B/C, 62.3%) and advanced disease (Barcelona Clinic Liver Cancer stage C, 36.7%). The 6-week rebleeding rates were 14.5% in group A and 18.5% in group B (p=0.576). The cumulative incidence of rebleeding was comparable between the two groups (p=0.909). On multivariate analysis, large (F 3 ) varices were an independent predictor of rebleeding (subdistribution HR 2.443; 95% CI 1.120 to 5.310). The 6-week mortality rates were 20.0% (11/55) in group A and 24.1% (13/54) in group B (p=0.608), with overall survival rates showing no significant difference (p=0.331). Conclusions Adding PPL to EBL offers no additional benefit over EBL alone for secondary prevention of EVB in patients with HCC, concerning rebleeding and survival outcomes. Trial registration number NCT01451658 .