Evaluating Safety and Pain Relief Using the NanoKnife System for Unresectable Pancreatic Cancer

What this Trial Is About

Researchers are evaluating the short and intermediate term safety of the NanoKnife Irreversible Electroporation IRE System when used off-label to treat unresectable pancreatic cancer. The study also aims to assess how well this device manages pain related to this condition and collects information about patients quality of life after the procedure. This observational study is sponsored by Englewood Hospital and Medical Center and focuses on patients with locally advanced pancreatic cancer that cannot be removed surgically. Participants will receive treatment using the NanoKnife System, a device approved by the FDA for soft tissue tumor ablation but not specifically cleared for pancreatic cancer treatment. The study observes patients after receiving this off-label therapy. Researchers will track safety and pain outcomes at multiple time points 1, 2, 4, 7, 14, 21, and 30 days, and then at 3, 6, 9, 12, 15, 18, 21, and 24 months post-procedure. Throughout the study, participants will be monitored for adverse events and changes in pain using the Visual Analogue Score VAS, as well as quality of life using EORTC QLQ-PAN26 and EORTC QLQ-C30 questionnaires. Safety assessments occur frequently early on and continue regularly for two years following treatment. This includes imaging evaluations before treatment to confirm eligibility and ongoing follow-up visits to evaluate health, symptoms, and overall well-being.

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