Liver and Bile
Gut. 2024;73(4):682–90
Endoscopic variceal ligation versus propranolol for the primary prevention of oesophageal variceal bleeding in patients with hepatocellular carcinoma: An open-label, 2-centre, randomised controlled trial
Objective: This randomised trial aimed to address whether endoscopic variceal ligation (EVL) or propranolol (PPL) is more effective at preventing initial oesophageal variceal bleeding (EVB) in patients with hepatocellular carcinoma (HCC).
Design: Patients with HCC and medium-to-large oesophageal varices (EVs) but without previous EVB were randomised to receive EVL (every 3–4 weeks until variceal eradication) or PPL (up to 320 mg daily) at a 1:1 ratio. Long-term follow-up data on EVB, other upper gastrointestinal bleeding (UGIB), non-bleeding liver decompensation, overall survival (OS) and adverse events (AEs) were analysed using competing risk regression.
Results: Between June 2011 and April 2021, 144 patients were randomised to receive EVL (n = 72) or PPL (n = 72). In the EVL group, 7 patients experienced EVB, and 30 died; in the PPL group, 19 patients had EVB, and 40 died. The EVL group had a lower cumulative incidence of EVB (Gray’s test, p = 0.009) than its counterpart, with no mortality difference (Gray’s test, p = 0.085). For patients with Barcelona Clinic Liver Cancer (BCLC) stage A/B, EVL was better than PPL in reducing EVB (p < 0.001) and mortality (p = 0.003). For patients beyond BCLC stage B, between-group outcomes were similar. Other UGIB, non-bleeding liver decompensation and AEs did not differ between groups. A competing risk regression model confirmed the prognostic value of EVL.
Conclusion: Endoscopic variceal ligation (EVL) is superior to propranolol in preventing initial oesophageal variceal bleeding (EVB) in patients with hepatocellular carcinoma. The benefits of EVL on EVB and overall survival may be limited to patients with Barcelona Clinic Liver Cancer (BCLC) stage A/B and not to those with BCLC stage C/D.