Efficacy of Irreversible Electroporation (IRE) for Central Colorectal Liver Metastases

Exclusion Criteria

• •Age more than 18 years;
• •ASA classification 0 - 3;
• •Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to definite inclusion:
• •* Hemoglobin ≥ 5.6 mmol/L;
• •* Absolute neutrophil count (ANC) ≥ 1,500/mm3;
• •* Platelet count ≥ 100\*109/l;
• •* Total bilirubin ≤ 1.5 times the upper limit of normal (ULN);
• •* ALT and AST ≤ 2.5 x ULN
• •* Serum creatinine ≤ 1.5 x ULN or a calculated creatinine clearance \> 50 ml/min;
• •* Prothrombin time or INR \< 1.5 x ULN;
• •* Activated partial thromboplastin time \< 1.25 x ULN (therapeutic anticoagulation therapy is allowed if this treatment can be interrupted as judged by the treating physician)
• •Written informed consent
• •Lesion \> 3,5 cm size;
• •History of epilepsy;
• •Extrahepatic metastases rendering local therapy unfeasible;
• •History of cardiac disease:
• •* Congestive heart failure \>NYHA class 2;
• •* Active Coronary Artery Disease (defined as myocardial infarction within 6 months prior to screening);
• •* Cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers are permitted);
• •Uncontrolled hypertension. Blood pressure must be ≤160/95 mmHg at the time of screening on a stable antihypertensive regimen;
• •Compromised liver function (e.g. signs of portal hypertension, INR \> 1,5 without use of anticoagulants, ascites);
• •Pregnant or breast-feeding subjects;
• •Immunotherapy ≤ 6 weeks prior to the procedure;
• •Chemotherapy ≤ 6 weeks prior to the procedure;
• •Concomitant use of anti-convulsives and anti-arrhythmic drugs other than beta blockers for antiepileptic or antiarrhythmic purpose;
• •Allergy to contrast media;
• •Any implanted stimulation device;
• •Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study