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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]

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]

Purpose: To describe safety and effectiveness of percutaneous irreversible electroporation (IRE) for treatment of unresectable, locally advanced pancreatic adenocarcinoma (LAPC)., Materials and Methods: This retrospective study included 50 patients (23 women, 27 men; age range, 46-91 y; median age, 62.5 y) with biopsy-proven, unresectable LAPC who received percutaneous computed tomography (CT)-guided IRE. The primary objective was to assess the safety profile of the procedure; the secondary objective was to determine overall survival (OS). All patients had prior chemotherapy (1-5 lines, median 2), and 30 (60%) of 50 patients had prior radiation therapy. Follow-up included CT at 1 month and at 3-month intervals thereafter., Results: There were no treatment-related deaths and no 30-day mortality. Serious adverse events occurred in 10 (20%) of 50 patients (abdominal pain [n = 7], pancreatitis [n = 1], sepsis [n = 1], gastric leak [n = 1]). Median OS was 27.0 months (95% confidence interval [CI], 22.7-32.5 months) from time of diagnosis and 14.2 months (95% CI, 9.7-16.2 months) from time of IRE. Patients with tumors ≤ 3 cm (n = 24) had significantly longer median OS than patients with tumors > 3 cm (n = 26): 33.8 vs 22.7 months from time of diagnosis (P = .002) and 16.2 vs 9.9 months from time of IRE (P = .031). Tumor size was confirmed as the only independent predictor of OS at multivariate analysis., Conclusions: Percutaneous image-guided IRE of unresectable LAPC is associated with an acceptable safety profile., (Published by Elsevier Inc.)

Irreversible electroporation (IRE) is a relatively new ablation modality that uses electric currents to cause cell death. It is commonly used to treat primary and secondary liver tumors in patients with normal liver function and preexisting cirrhosis. Retrospective analysis of 205 procedures sought to evaluate changes in liver function after IRE. Liver function tests (LFTs) results before and after IRE were evaluated from 174 procedures in 124 patients. Aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (ALKP), and total bilirubin levels were analyzed. The study was Health Insurance Portability and Accountability Act compliant and institutional review board approved. Informed consent was waived. Changes in LFT results after IRE were compared with baseline and were followed up over time to see if they resolved. Changes were compared with volume of ablation. The greatest perturbations were in transaminase levels. The levels increased sharply within 24 hours after IRE in 129 (74.1%) procedures to extreme levels (more than 20 times the upper limit of normal in one-third of cases). Resolution occurred in 95% and was demonstrated to have occurred by a mean of approximately 10 weeks, many documented as early as 7 days after procedure. ALKP levels elevated in 10% procedures, was slower to increase, and was less likely to resolve. Total bilirubin level demonstrated 2 different patterns of elevation--early and late--and similar to ALKP, it was more likely to remain elevated. There was no increased risk in patients with cirrhosis or cholangiocarcinoma. There was no correlation of levels with volume of ablation. IRE results in significant abnormalities in LFT results, but in most of the cases, these are self-limiting, do not preclude treatment, and are similar to the changes seen after radiofrequency and cryoablation in the liver., (Copyright © 2015. Published by Elsevier Inc.)

Purpose: The purpose of this study was to evaluate need for antibiotic prophylaxis for radiofrequency ablation (RFA) of liver tumors in patients with no significant co-existing risk factors for infection., Materials and Methods: From January 2004 to September 2013, 83 patients underwent 123 percutaneous RFA procedures for total of 152 hepatocellular carcinoma (HCC) lesions. None of the patients had pre-existing biliary enteric anastomosis (BEA) or any biliary tract abnormality predisposing to ascending biliary infection or uncontrolled diabetes mellitus. No pre- or post-procedure antibiotic prophylaxis was provided for 121 procedures. Data for potential risk factors were reviewed retrospectively and analyzed for the frequency of infectious complications, including abscess formation., Results: One patient (1/121 (0.8%) RFA sessions) developed a large segment 5 liver abscess/infected biloma communicating with the gallbladder 7 weeks after the procedure, successfully treated over 10 weeks with IV and PO antibiotic therapy and percutaneous catheter drainage. This patient did not receive any antibiotics prior to RFA. During the procedure, there was inadvertent placement of RFA probe tines into the gallbladder. No other infectious complications were documented., Conclusion: These data suggest that the routine use of prophylactic antibiotics for liver RFA is not necessary in majority of the patients undergoing liver ablation for HCC and could be limited to patients with high-risk factors such as the presence of BEA or other biliary abnormalities, uncontrolled diabetes mellitus, and large centrally located tumors in close proximity to central bile ducts. Larger randomized studies are needed to confirm this hypothesis.