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14. Percutaneous irreversible electroporation (IRE) in the management of pancreatic cancer.

Author

Narayanan, G., Froud, T., Suthar, R., Barbery, K.J., and Yrizarry, J.

Abstract

Purpose: Prospective survival and safety outcomes were evaluated in patients with pancreatic adenocarcinoma treated using IRE. Inclusion criteria included unresectability of primary tumor and intolerance of standard therapy. Survival rates were calculated using Kaplan Meier analysis. Materials and Methods: Thirty four patients with localized advanced pancreatic cancer (LAPC) (n=23) and metastatic pancreatic cancer (MPC) (n=11) underwent 39 IRE procedures; 5 patients were treated twice, 2 for recurrent disease, 3 due to large tumor burden. All procedures were performed under general anesthesia with CT scan guidance and complete muscle relaxation. Three procedures were cancelled due to lack of a safe window, one was aborted prior to IRE treatment due to self-limiting bleed during needle placement. Results: Overall median survival was 27 months (95% CI: 15.5-38.5 months) from the date of diagnosis and 10.8 months (95% CI: 3.3-18.2 months) from the date of IRE. Separating into two groups based on stage, LAPC patients (n=23) overall median survival was 33.8 months (95% CI: 20.5-47.1 months) and 16.2 months (95% CI: 8.5-23.9 months) versus MPC patients overall median survival 16.9 months (95% CI: 1.3-39.2 months) and 7.1 months (95% CI: 4.8-9.4 months) from date of diagnosis and date of IRE respectively. Two patients underwent surgery 4 and 5 months after IRE, respectively. Both had margin-negative (R0) resections; one of the two had biopsy proven recurrence 34 months post IRE and the second remains disease-free at 26.5 months. Complications included pancreatitis (n=5), abdominal pain (n=5), hematoma (n=3), spontaneous pneumothorax (n=1), duodenal stent (n=1) and sepsis at 48 hours post IRE (n=1). Fifteen patients have expired, and no deaths were directly related to the procedure. Conclusion: IRE can prolong survival in carefully selected patients with adenocarcinoma of the pancreas. This benefit is more apparent in patients with LAPC compared to those with metastatic disease. In certain circumstances it may lead to resectability of disease. Further evaluation to define the role of IRE in the management of pancreatic carcinoma is warranted. [Copyright &y& Elsevier]

Published
2014
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35. International trial of the Edmonton protocol for islet transplantation.

Author

Shapiro AMJ, Ricordi C, Hering BJ, Auchincloss H, Lindblad R, Robertson RP, Secchi A, Brendel MD, Berney T, Brennan DC, Cagliero E, Alejandro R, Ryan EA, DiMercurio B, Morel P, Polonsky KS, Reems J, Bretzel RG, Bertuzzi F, and Froud T

Abstract

Background: Islet transplantation offers the potential to improve glycemic control in a subgroup of patients with type 1 diabetes mellitus who are disabled by refractory hypoglycemia. We conducted an international, multicenter trial to explore the feasibility and reproducibility of islet transplantation with the use of a single common protocol (the Edmonton protocol).Methods: We enrolled 36 subjects with type 1 diabetes mellitus, who underwent islet transplantation at nine international sites. Islets were prepared from pancreases of deceased donors and were transplanted within 2 hours after purification, without culture. The primary end point was defined as insulin independence with adequate glycemic control 1 year after the final transplantation.Results: Of the 36 subjects, 16 (44%) met the primary end point, 10 (28%) had partial function, and 10 (28%) had complete graft loss 1 year after the final transplantation. A total of 21 subjects (58%) attained insulin independence with good glycemic control at any point throughout the trial. Of these subjects, 16 (76%) required insulin again at 2 years; 5 of the 16 subjects who reached the primary end point (31%) remained insulin-independent at 2 years.Conclusions: Islet transplantation with the use of the Edmonton protocol can successfully restore long-term endogenous insulin production and glycemic stability in subjects with type 1 diabetes mellitus and unstable control, but insulin independence is usually not sustainable. Persistent islet function even without insulin independence provides both protection from severe hypoglycemia and improved levels of glycated hemoglobin. (ClinicalTrials.gov number, NCT00014911 [ClinicalTrials.gov].). [ABSTRACT FROM AUTHOR]

Published
2006

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