Evaluation of Tumor Ablation Effects by Irreversible Electroporation for Patients With Malignant Liver Tumors

Inclusion criteria

• The diagnosis of HCC or other cancers with hepatic metastatic with pathologic proven.
• The diagnosis of HCC will be made by pathology / cytology or according to the AASLD(2010) diagnostic criteria. In brief, Nodules larger than 1 cm found on ultrasound screening of a cirrhotic liver should be investigated further with either 4-phase multidetector CT scan or dynamic contrast enhanced MRI. If the appearances are typical of HCC (i.e., hypervascular in the arterial phase with washout in the portal venous or delayed phase), the lesion should be treated as HCC. If the findings are not characteristic or the vascular profile is not typical, a second contrast enhanced study with the other imaging modality should be performed, or the lesion should be biopsied. Biopsies of small lesions should be evaluated by expert pathologists. Tissue that is not clearly HCC should be stained with all the available markers including CD34, CK7, glypican 3, HSP-70, and glutamine synthetase to improve diagnostic accuracy.
• Suitable for surgical resection, but the distance between tumors and preserved vessels is less than 5 mm. Adequate safe margin can not be obtained.
• There are at least one tumor, but less than or equal to 3 tumors,
• Each tumor must be ≤ 5 cm in diameter,
• Child-Pugh class A-B,
• Eastern Cooperative Oncology Group (ECOG) score of 0-1,
• American Society of Anaesthesiologists (ASA) score ≤ 3,
• Platelet count ≥ 100 K/Μl
• Total bilirubin ≦ 2 mg/dL
• ALT and AST < 5 x upper limit of normal
• PT-INR ≦ 2.0, or PT < 6 seconds above control
• Serum creatinine ≦ 1.5 x upper limit of normal
• Prior Informed Consent Form
• Life expectancy of at least 3 months.

Exclusion criteria

• Congestive heart failure >New York Heart Association (NYHA) class 2
• Active coronary artery disease (CAD) (myocardial infarction more than 6 months prior to study entry is allowed)
• Cardiac arrhythmias (>Grade 2 NCI-CTCAE Version 3.0) which are poorly controlled with anti-arrhythmic therapy or requiring pace maker
• Uncontrolled hypertension
• Any active metal implanted device (eg Pacemaker),
• Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
• Received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ IRE System,
• Known history of HIV infection
• Concurrent primary extrahepatic cancer