Safety and Feasibility of Irreversible Electroporation (IRE) in Patients with Locally Advanced Pancreatic Cancer: Results of a Prospective Study

Abstract

Purpose: 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.

The efficacy of combination of induction chemotherapy and irreversible electroporation ablation for patients with locally advanced pancreatic adenocarcinoma

“…The recurrence rates of the patients in this study compare favourably to those of other studies as well; 8.6% displayed local recurrence, which is compared to the 58% from the study by Mansson et al and the 30% from the study conducted by Paiella et al For a comparison of the results across published literature, see Table . The survival benefits that are derived from multiple published studies point to the effectiveness of IRE as a treatment modality and detail the overall survival from the procedure.…”

A Single-institution Experience with Open Irreversible Electroporation for Locally Advanced Pancreatic Carcinoma

“…The morbidity was consistent with several recent overlapping multi-institutional studies investigating IRE management of LAPC, in which the 90-day complication rates ranged from 33% to 59%. [91820] Although our total complication rate was relatively high, all intraoperative complications were transient, and the postoperative complication rate was only 36%. Moreover, the Clavien-Dindo grades tended to be less severe; only 8% of patients had Grade 3 complications in a manner that involved upper gastrointestinal hemorrhaging.…”

“…In our protocol, IRE is absolutely contraindicated in patients with severe cardiac arrhythmias or pacemakers, or with implanted biliary metallic stents; this was in accordance with the previous clinical studies at other centers. [918] Intolerance to muscle relaxants and anticoagulants is also considered an absolute contraindication because these agents are indispensable during the perioperative period. Furthermore, the tumor diameter is a crucial parameter when evaluating IRE applicability; it was previously recommended that tumor sizes be limited to <4 cm for better efficacy.…”

Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines

“…Tumor ablation requires ~100 pulses and these are delivered between heartbeats to avoid arrhythmias. This non-thermal technique has also been used to ablate tumors in pancreas, lung, kidney, gastrointestinal tract, brain, breast, cervix, prostate and sarcomas (Lu et al, 2013; Paiella et al, 2015; Ting et al, 2016). …”