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

Cancer Commun (Lond). 2024 Nov;44(11):1337-1349. doi: 10.1002/cac2.12614. Epub 2024 Sep 25.

Abstract

Background: The widely accepted view that portal hypertension (PHT) is a contraindication to hepatectomy for patients with hepatocellular carcinoma (HCC) is being increasingly challenged. The long-term survival outcomes and safety of partial hepatectomy versus interventional treatment using ablation with or without pre-ablation transarterial chemoembolization (TACE) in patients with HBV-related HCC within the Milan criteria and with clinically significant PHT were compared in this study.

Methods: This open-label randomized clinical trial was conducted on consecutive patients with clinically PHT and hepatitis B virus (HBV)-related HCC with tumors which were within the Milan criteria. These patients were randomized 1:1 to receive either partial hepatectomy or interventional treatment between December 2012 and June 2018. The primary endpoint was overall survival (OS); secondary endpoints included recurrence-free survival (RFS) and therapeutic safety.

Results: Each of the 2 groups had 80 patients. The 1-, 3- and 5-year OS rates in the partial hepatectomy group and the interventional treatment group were 95.0%, 86.2%, 69.5% versus 93.8%, 77.5%, 64.9%, respectively (P = 0.325). The corresponding 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 complication 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 (All P > 0.05).

Conclusions: This study shows that partial hepatectomy treatment did not meet prespecified significance for improved OS and RFS compared to interventional treatment for patients with HBV-related HCC within the Milan criteria and with clinically significant PHT. However, partial hepatectomy is still a safe procedure and should be considered as a treatment option rather than a contraindication.

Keywords: hepatocellular carcinoma; interventional treatment; partial hepatectomy; portal hypertension.

Publication types

  • Randomized Controlled Trial
  • Comparative Study

MeSH terms

  • Adult
  • Aged
  • Carcinoma, Hepatocellular* / complications
  • Carcinoma, Hepatocellular* / surgery
  • Carcinoma, Hepatocellular* / therapy
  • Carcinoma, Hepatocellular* / virology
  • Chemoembolization, Therapeutic / methods
  • Female
  • Hepatectomy* / adverse effects
  • Hepatitis B / complications
  • Hepatitis B virus
  • Humans
  • Hypertension, Portal* / etiology
  • Hypertension, Portal* / surgery
  • Hypertension, Portal* / therapy
  • Liver Neoplasms* / complications
  • Liver Neoplasms* / surgery
  • Liver Neoplasms* / therapy
  • Liver Neoplasms* / virology
  • Male
  • Middle Aged
  • Treatment Outcome