Ablation of Unresectable Locally Advanced Pancreatic Cancer With Irreversible Electroporation (IRE) System

Patients with pancreatic ductal adenocarcinoma will be screened by pancreatic protocol cross-sectional imaging to see if they have locally advanced unresectable pancreatic ductal adenocarcinoma. Patients with unresectable disease will undergo at least four cycles of standard of care chemotherapy before being re-evaluated for treatment with irreversibe electroporation (i.e., Nanoknife). If patients are over 18 years of age, have pancreatic tumor size less than 5cm, and can safely undergo a laparotomy, they will be considered for participation. The patient cannot undergo the procedure if they have metastatic disease, a pacemaker or an electrostimulator, a metallic stent that cannot be exchanged, a convulsive (i.e., epilepsy) condition, an estimated survival less than three months, atrial fibrillation with an undetectable waveform on ECG sync device, severe cardiac disease, a international normalised ratio (INR) that is less than 1.5, or a performance status \>2. For the procedure, a laparotomy will be performed and Nanoknife probe placement will be done under intraoperative ultrasound. The number of probes, depth of the probes and rapid pulse series will be decided by the surgeon and are based on the size and location of the desired area of ablation. Patients will be followed for overall survival, progression-free survival, tumor response, tumor markers, symptom improvement, and complications. Symptom improvement will be measured by assessment of pain, quality of life, total bilirubin if biliary obstruction is initially present, and oral intake if gastric outlet obstruction is initially present. They will have regular follow up with the surgeon that will include routine surveillance imaging and blood work.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* age \>18
* locally advanced unresectable pancreatic ductal adenocarcinoma as demonstrated by CT or MRI
* must have received standard chemotherapy and completed at least four cycles of treatment at least 5 weeks prior to therapy with Nanoknife
* INR \<1.5
* able to tolerate laparotomy (medical/cardiac clearance as needed)
* able to comply with protocol requirements
* women of childbearing potential must have a negative serum pregnancy test and be practicing an effective form of birth control

Exclusion Criteria:

* patients with tumor \>5cm after completion of chemotherapy
* presence of metastatic disease
* patients with a pacemaker or electrostimulator
* estimated survival is less than 3 months
* presence of a metallic stent (biliary or duodenal) which cannot be removed or exchanged for plastic
* ECOG performance status more than or equal to 2
* epilepsy or other convulsive conditions
* cannot tolerate general anesthesia
* patients with atrial fibrillation who have an undetectable wave form on the ECG synchronization device
* patients with inducible ischemia on cardiac stress test or uncontrolled angina
* white blood cell count less than or equal to 2,000, absolute neutrophil count \<1,000, platelets \<50,000