title: Safety and feasibility of Irreversible Electroporation (IRE) in patients with locally advanced pancreatic cancer: results of a prospective study.
abstract: OBJECTIVE
  To evaluate the safety of the NanoKnife Low Energy Direct Current (LEDC) System (Irreversible Electroporation, IRE) in order to treat patients with unresectable pancreatic adenocarcinoma.
  
  
  METHODS
  Prospective, nonrandomized, single-center clinical evaluation of ten patients with a cytohystological diagnosis of unresectable locally advanced pancreatic cancer (LAPC) that was no further responsive to standard treatments. The primary outcome was the rate of procedure-related abdominal complications. The secondary endpoints included the evaluation of the short-term efficacy of IRE through the evaluation of tumor reduction at imaging and biological tumor response as shown by CA 19-9, clinical assessments and patient quality of life.
  
  
  RESULTS
  Ten patients (5 males, 5 females) were enrolled, with a median age of 66 and median tumor size of 30 mm. All patients were treated successfully with a median procedure time of 79.5 min. Two procedure-related complications were described in one patient (10%): a pancreatic abscess with a pancreoduodenal fistula. Three patients had early progression of disease: one patient developed pulmonary metastases 30 days post-IRE and two patients had liver metastases 60 days after the procedure. We registered an overall survival of 7.5 months (range: 2.9-15.9).
  
  
  CONCLUSIONS
  IRE is a safe procedure in patients with LAPC and may represent a new technological option in the treatment and multimodality management of this disease.
authors.affiliation: Unit of Pancreatic and General Surgery, The Pancreas Institute, G.B. Rossi Hospital, University of Verona Hospital Trust, Verona, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Paiella
authors.forename: Giovanni
authors.initials: G
authors.lastname: Butturini
authors.forename: Isabella
authors.initials: I
authors.lastname: Frigerio
authors.forename: Roberto
authors.initials: R
authors.lastname: Salvia
authors.forename: Giulia
authors.initials: G
authors.lastname: Armatura
authors.forename: Matilde
authors.initials: M
authors.lastname: Bacchion
authors.forename: Martina
authors.initials: M
authors.lastname: Fontana
authors.forename: Mirko
authors.initials: M
authors.lastname: D'Onofrio
authors.forename: Enrico
authors.initials: E
authors.lastname: Martone
authors.forename: Claudio
authors.initials: C
authors.lastname: Bassi
mesh_terms: D000230:Adenocarcinoma / Q000601:surgery*; D000368:Aged; D018274:Electroporation; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D010190:Pancreatic Neoplasms / Q000601:surgery*; D011183:Postoperative Complications; D011446:Prospective Studies; D011788:Quality of Life; D016896:Treatment Outcome