Table 1.
Summary of clinical studies of irreversible electroporation (IRE) in pancreatic cancer (PC).
| Study Description/Type | Pulse | Number of Patients (Procedure and Type of IRE) | Tumor Size Med. (Range), cm | Main Findings/Outcomes | Adverse Events/Mortality | Median Overall Survival, mo. | Ref. |
|---|---|---|---|---|---|---|---|
| Study on the LAPC patients treated with IRE. Ninety-day follow-up for morbidity, mortality, and local disease control/prospective. | M (23) B (4) |
27 (19 IRE, 8 IRE + resection; 26-OP, 1P) | 3 (1–5.5) | IRE is safe and feasible on PC. No evidence of residual tumor during follow-up. No reports of clinical pancreatitis or fistula formation during the 90-day follow-up/palliation of pain symptoms and reduction of overall narcotic use. | Major 33%/ Mortality 4% |
NR | Martin et al., 2012 [39] |
| IRE performed in PC patients with unresectable tumors. The evaluation of tumor response, adverse events, and survival. | M B |
14 (3 with metastatic disease and 11 with LAPC; P) | 3.3 (2.5–7) | The authors conclude that IRE is feasible and safe. No survival benefits for patients with metastatic disease/two patients had R0 resection after IRE and stayed disease free 11 and 14 months. No serious complications reported. | NR/NR Patients with the metastatic disease died due to the progression |
NR | Narayanan et al., 2012 [40] |
| Evaluation of overall survival of patients treated with IRE vs. standard therapy (chemotherapy and radiation therapy alone)/prospective. | M (48) B (6) |
54 (OP-52, P-2) | 3.2 (1–5.5) | Better progression-free survival with greater local palliation. 20.2 mo. of OS with IRE+ chemotherapy vs. 11 mo. after chemotherapy alone. |
67 | 20.2 | Martin et al., 2013 [41] |
| Assessment of the efficacy of IRE as part of multimodal treatment in stage III LAPC patients. In a prospective multicenter study, the determination of perioperative 90-day outcomes, local failure, and OS. | M | 200 (150 IRE, 50 IRE+ resection); OP | 3 (1.6–7) | IRE on LAPC patients after chemotherapy and chemoradiotherapy resulted in prolonged survival. During 29 months, follow-up six patients have a local recurrence. | 37%/NR | 24.9 | Martin et al., 2015 [23] |
| Single institution clinical trial, determination of perioperative morbidity and mortality for LAPC patients treated with IRE. | M | 50 (29 IRE, 24 margin extension IRE); OP | 3.0 (1.7–5) | The mortality and morbidity rates were higher than reported before. There is a need for further research on the safety and efficacy of IRE in PC. IRE should not be considered a minimally invasive treatment. | 16/mortality 6 (11%) in 90-day follow-up (5 with IRE) | IRE 7.71 |
Kluger et al., 2015 [42] |
| Patients with LAPC with no evidence of metastasis pretreated with chemo-/and or radiotherapy were treated with percutaneous CT-guided IRE. | M | 24, P-US-guided | 3.5 (1.5–4.5) | Downstaging in two patients, local control in 9 patients. The study confirmed the safety and efficacy of IRE procedure, but more study is needed to improve the outcomes of the procedure. | 11 (3 severe, 8 minor)/NR | 17.9 (7 after IRE) | Mansson et al., 2016 [43] |
| Retrospective study to define safety and efficacy of percutaneous IRE for treatment of LAPC. | M (45) B (5) |
50, P | 3.4 (1–6) | Downstaging in case of 3 patients. Studies indicated that tumor size < 3 is the only objective predictor of overall survival. | 45 (35 mild/10 serious)/NR | 27 (14.2 from IRE) | Naraynan et al., 2017 [44] |
| The phase I/II PANFIRE study of ablation with percutaneous IRE of LAPC. Evaluation of safety, efficacy, quality of life, pain perception, event-free survival OS/prospective. | M | 25, P | 4 (3.3–5) | IRE is generally well tolerated. Only three patients had signs of pancreatitis, although major avert effects can occur. Median event-free survival after IRE—8 mo. Time of local progression 12 mo. |
23 (11 major/11minor)/NR | 11 | Scheffer et al., 2017 [45] |
| Treatment of patients with unresectable LAPC with CT-guided IRE. The evaluation of postoperative immediate and 30-day morbidity and mortality, progression-free (PFS), and overall survival (OS). | M | 75 P | 3.47 ± 1.2 | Studies showed the safety and ability to combine IRE procedures in unresectable LAPC patients with standard chemotherapy for better OS and PFS. Median progression-free survival post-IRE was 15 mo. Four patients downstage after IRE ablations which allowed R0 resection in 3 cases. | 25%/NR | 27 | Leen et al., 2018 [46] |
| Multicenter study for evaluation of safety and efficacy of IRE in LAPC patients treated with laparotomic and laparoscopic IRE with prior treatment with gemcitabine or TS-1 chemotherapy. | NA | 70 (65 OP, 5 laparoscopic) | NA | IRE is safe and effective for the control of LAPC. The addition of IRE to a chemotherapy regimen improves survival. PFS 15.4 mo. (13.2 in the gemcitabine group, 26.4 in the TS-1 group). | 30 (3 major, 27 minor)/NR | 22.6 (19.1 gemcitabine-based reagents, 28.7 TS-1) | Sun et al., 2021 [25] |
| Determination of safety and efficacy of IRE with or without chemotherapy for unresectable pancreatic carcinoma (stage III/IV). Prospective |
M | 54; OP, P | 4.9 | Pancreatic cancer patients may benefit from IRE, which has improved OS in certain patients who also received chemotherapy. IRE was generally well tolerated. IRE can provide local tumor control with relatively satisfactory PFS and OS in stage III and IV pancreatic cancer patients with large tumors (>5 cm). |
4 major/44 minor | 16.6 20.3 IRE + chemotherapy |
Liu et al., 2019 [47] |
| A multicenter, prospective phase II study of percutaneous IRE for LAPC and recurrent PC. | 50 (40 LAPC, 10 local recurrences); CT guided IRE, P | 3.7 | IRE should be considered a high-risk procedure due to the possibility of major adverse effects. The study suggests survival benefits from IRE compared to standard-of-care. | 21 major, 14 minor/2 deaths within 90 days of IRE | 17 from diagnosis 11.6 IRE 14.9 IRE+ FOLFIRINOX |
Ruarus et al., 2020 [48] |
Abbreviations: IRE; irreversible electroporation, M; monopolar, B; bipolar, OP; open, P; percutaneous, OS; overall survival rate, mo; months, LAPC; locally advanced pancreatic cancer; PFS, progression-free survival, NA; not available, NR; not reported.