Partial hepatectomy versus interventional treatment in patients with hepatitis B virus-related hepatocellular carcinoma and clinically significant portal hypertension: a randomized comparative clinical trial

Background:The widely accepted view that portal hypertension (PHT) is a con-traindication to hepatectomy for patients with hepatocellular carcinoma (HCC)is being increasingly challenged. The long-term survival outcomes and safetyof partial hepatectomy versus interventional treatment using ablation with orwithout pre-ablation transarterial chemoembolization (TACE) in patients withHBV-related HCC within the Milan criteria and with clinically significant PHTwere compared in this study. Methods:This open-label randomized clinical trial was conducted on consecu-tive patients with clinically PHT and hepatitis B virus (HBV)-related HCC withtumors which were within the Milan criteria. These patients were randomized1:1 to receive either partial hepatectomy or interventional treatment betweenDecember 2012 and June 2018. The primary endpoint was overall survival (OS);secondary endpoints included recurrence-free survival (RFS) and therapeuticsafety. Results:Each of the 2 groups had 80 patients. The 1-, 3- and 5-year OS ratesin the partial hepatectomy group and the interventional treatment group were95.0%, 86.2%, 69.5% versus 93.8%, 77.5%, 64.9%, respectively (P=0.325). Thecorresponding RFS rates were 78.8%, 55.0%, 46.2% versus 71.3%, 52.5%, 45.0%,respectively (P=0.783). The partial hepatectomy group had a higher compli-cation rate compared to the interventional group (67.5% vs. 20%,P<0.001).However, the differences were mainly in Clavien-Dindo Grade I complications(P<0.001), while not significant in Grade II/III/IV/V (AllP>0.05). Conclusions:This study shows that partial hepatectomy treatmentdid not meetprespecified significance for improved OS and RFS compared to interventionaltreatment for patients with HBV-related HCC within the Milan criteria and withclinically significant PHT. However, partial hepatectomy is still a safe procedureand should be considered as a treatment option rather than a contraindication.