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

Inclusion criteria

• Histological or cytological documentation of primary colorectal tumor;
• Previous induction chemotherapy due to unresectability; no intra- or extrahepatic disease progression under induction chemotherapy; OR
• Previous chemotherapy for other CRLM, now presenting with renewed CRLM unsuitable for resection or thermal ablation;
• Liver metastases F-18-FDG PET avid and visible on ceCT, size ≤ 3,5 cm and not eligible for resection or thermal ablation due to location close to a vessel or bile duct;
• 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

Exclusion criteria

• 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