Irreversible Electroporation for Nonthermal Tumor Ablation in Patients with Locally Advanced Pancreatic Cancer: Initial Clinical Experience in Japan

Objective To evaluate irreversible electroporation (IRE) for locally advanced pancreatic cancer (LAPC). Methods This study was approved by our local review board. Eight patients with histologically proven LAPC <= 5 cm were prospectively enrolled to undergo ultrasound-guided IRE. The primary endpoint was complications within 90 days. Secondary outcomes were the overall survival (OS) and time to local progression. Safety was assessed using Common Terminology Criteria for Adverse Events Version 4.0. Results All patients were treated successfully. The median procedure time was 150 min. The median largest tumor diameter was 29.5 mm (20.0-48.0 mm) in the pancreatic head (n=5) and body (n=3). Open (n=4) and percutaneous (n=4) approaches were used. No patients died within 90 days after IRE. There were 5 minor complications in 3 patients and 4 major complications in 3 patients. The incidence rates of major complications did not differ significantly between the approaches. The median time to local progression after IRE was 12.0 months, and the median OS was 17.5 months from IRE and 24.0 months from the diagnosis, with no significant differences between the approaches. Conclusions Percutaneous and open IRE may be acceptable for patients with LAPC (despite some major adverse events) and may represent a useful new therapeutic option.