International Study on Treatment of Liver (HCC) Patients With IRE

Prior treatment

• Prior hepatic tumour ablation.
  • Cardiovascular fitness related exclusions:

Other illness

• History of ventricular arrhythmia.
• Congestive cardiac failure NYHA Class ≥ 3.
  • Tumour-related exclusions:
• Extrahepatic metastatic disease.

Lab values

• Impaired renal function (serum creatinine \> 150 µmol/L)
• Platelet count \< 50x109 U/L.
• International normalised ratio (INR) for blood clotting \> 1.7.
• Jaundice (serum bilirubin \> 30 µmol/L).

Age

• Patients under the age of 18 years.

Other

• General:
• Patients involved in other research studies.
• Inability to give informed consent.
• Patients who are pregnant.
• Child-Pugh B or C.
• Patients with an ECOG status of \> 2 at time of recruitment.
• Rockwood Frailty Score \> 3
• Accepted exclusions to IRE from consensus criteria including:
• Implanted pacemaker or defibrillator.
• Tumour ≥ 3 cm in size.
• MDT recommends use of thermal ablation for any given lesion.

• Patients aged 18 years and over, able to provide informed consent and with clinical diagnosis of an HCC. Tissue confirmation of HCC prior to treatment is not standard of care and is therefore not required for this study.
• Child-Pugh A up to A6.
• Eastern Co-operative Oncology Group (ECOG) Score ≤ 2.
• Rockwood Frailty Score ≤ 3.
• Serum bilirubin \< 30 µmol/L.
• Serum creatinine \< 150 µmol/L.
• No extrahepatic metastases
• IRE can be used for up to 3 tumours \< 3cm in size. Other forms of ablation can be combined with IRE in the same sitting but not for the same lesion. IRE can also be combined with surgical resection.