Percutaneous Irreversible Electroporation for Unresectable Hepatic Carcinoma in Poor Liver Function

Hepatic carcinoma is the fifth most common cancer worldwide and a large proportion of patients are unsuitable for tumor resection because of factors such as poor hepatic reserve(cirrhosis) which directly lead a poor liver function. Direct ablative treatments include radiofrequency ablation, microwave (MW) ablation and cryotherapy and irreversible electroporation had been used successful as a therapeutic choice for unresectable patients. At the same time，Irreversible electroporation(IRE)，which was applied with a novel ablation technology, can induce tissue necross by utilizing short pulses of high-voltage electrical energy. The technique also had many advantages, including Short ablation time, preservation of vital structures within IRE-ablated zone, avoidance of heat/cold-sink effect, complete ablation with well-demarcated margin and real-time monitoring of IRE ablation.

Inclusion criteria

• Hepatic carcinoma diagnosed by positive biopsy or non-invasive criteria,
• not suitable for surgical resection or transplantation,
• have at least one, but less than or equal to 3 tumors,
• of the tumour(s) identified, each tumor must be ≤ 5 cm in diameter,
• Child-Pugh class B or ≤12，
• Eastern Cooperative Oncology Group (ECOG) score of 0-1,
• American Society of Anaesthesiologists (ASA) score ≤ 3,
• a prothrombin time ratio > 50%,
• platelet count > 80x109/L,
• ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
• are able to comprehend and willing to sign the written informed consent form (ICF),
• have a life expectancy of at least 3 months.

Exclusion criteria

• eligible for surgical treatment or transplantation for HCC,
• Hepatic carcinoma developed on an already transplanted liver,
• cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
• any active implanted device (eg Pacemaker),
• women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
• have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System, are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.