Outcomes of Ablation of Unresectable Pancreatic Cancer Using the NanoKnife Irreversible Electroporation System-

Exclusion Criteria

• •Creatinine \> 2.0 mg/dL
• •Any lab value with a grade 3 or 4 toxicity as defined by the CTCAE Version 5.0
• •Inability to stop antiplatelet and coumadin therapy for 7 days prior to and 7 days post treatment with the NanoKnife System
• •Tumor size not measurable
• •Known history of contrast allergy that cannot be medically managed
• •Known hypersensitivity to the metal in the electrodes (stainless steel 304L) that cannot be medically managed
• •Unable to be treated with a muscle blockade agent (e.g. pancuronium bromide, atracurium, cisatracurium, etc.)
• •Women who are pregnant or currently breast feeding
• •Women of childbearing potential who are not utilizing an acceptable method of contraception
• •Have taken an investigational agent within 30 days of visit 1
• •Have implanted cardiac pacemakers or defibrillators
• •Have implanted electronic devices or implants with metal parts in the vicinity of a lesion
• •Have a history of epilepsy or cardiac arrhythmia (atrial or ventricular fibrillation)
• •Have a recent history of myocardial infarction (within the past 2 months)
• •Have Q-T intervals greater than 550 ms unless treated with an Accysync Model 72 synchronization system controlling the NanoKnife system's output pulses
• •Evidence of distant metastases of stage IV
• •Have taken any chemotherapeutic agent within 5 weeks of treatment with the NanoKnife Irreversible Electroporation (IRE) System
• •Received non-conventional fractionation schedules, such as stereotactic radiation (5 fractions or less) or received higher than 54 Gray (Gy) delivered conventionally