Background
Locally advanced unresectable pancreatic adenocarcinoma (LAC) is characterized by poor survival despite chemotherapy and conventional radiation therapy. We have recently reported on the ...safety of using irreversible electroporation (IRE) for the management of LAC. The purpose of this study was to evaluate the overall survival in patients with LAC treated with IRE.
Methods
A prospective, multi-institutional evaluation of 54 patients who underwent IRE for unresectable pancreatic cancer from December 2009 to October 2010 was evaluated for overall survival and propensity matched to 85 matched stage III patients treated with standard therapy defined as chemotherapy and radiation therapy alone.
Results
A total of 54 LAC patients have undergone IRE successfully, with 21 women, 23 men (median age, 61 (range, 45–80) years). Thirty-five patients had pancreatic head primary and 19 had body tumors; 19 patients underwent margin accentuation with IRE and 35 underwent in situ IRE. Forty-nine (90 %) patients had pre-IRE chemotherapy alone or chemoradiation therapy for a median duration 5 months. Forty (73%) patients underwent post-IRE chemotherapy or chemoradiation. The 90 day mortality in the IRE patients was 1 (2 %). In a comparison of IRE patients to standard therapy, we have seen an improvement in local progression-free survival (14 vs. 6 months,
p
= 0.01), distant progression-free survival (15 vs. 9 months,
p
= 0.02), and overall survival (20 vs. 13 months,
p
= 0.03).
Conclusions
IRE ablation of locally advanced pancreatic tumors remains safe and in the appropriate patient who has undergone standard induction therapy for a minimum of 4 months can achieve greater local palliation and potential improved overall survival compared with standard chemoradiation–chemotherapy treatments. Validation of these early results will need to be validated in the current multi-institutional Phase 2 IDE study.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
Background Locally advanced pancreatic cancer patients have limited options for disease control. Local ablation technologies based on thermal damage have been used but are associated with major ...complications in this region of the pancreas. Irreversible electroporation (IRE) is a nonthermal ablation technology that we have shown is safe near vital vascular and ductal structures. The aim of this study was to evaluate the safety and efficacy of IRE as a therapy in the treatment of locally advanced pancreatic cancer. Study Design We performed a prospective multi-institutional pilot evaluation of patients undergoing IRE for locally advanced pancreatic cancer from December 2009 to March 2011. These patients were evaluated for 90-day morbidity, mortality, and local disease control. Results Twenty-seven patients (13 women and 14 men) underwent IRE, with median age of 61 years (range 45 to 80 years). Eight patients underwent margin accentuation with IRE in combination with left-sided resection (n = 4) or pancreatic head resection (n = 4). Nineteen patients had in situ IRE. All patients underwent successful IRE, with intraoperative imaging confirming effective delivery of therapy. All 27 patients demonstrated nonclinically relevant elevation of their amylase and lipase, which peaked at 48 hours and returned to normal at 72 hour postprocedure. There has been one 90-day mortality. No patient has shown evidence of clinical pancreatitis or fistula formation. After all patients have completed 90-day follow-up, there has been 100% ablation success. Conclusions IRE ablation of locally advanced pancreatic cancer tumors is a safe and feasible primary local treatment in unresectable, locally advanced disease. Confirming these early results must occur in a planned phase II investigational device exemption (IDE) study to be initiated in 2012.
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GEOZS, NUK, OILJ, SBJE, UL, UPUK
Background Intraoperative evaluation of successful pancreatic tumor ablation using irreversible electroporation (IRE) is difficult secondary to lack of visual confirmation. The IRE generator provides ...feedback by reporting current (amperage), which can be used to calculate changes in tumor tissue resistance. The purpose of the study was to determine if resistance can be used to predict successful tumor ablation during IRE for pancreatic cancers. Study Design All patients undergoing pancreatic IRE from March 2010 to December 2012 were evaluated using a prospective database. Intraoperative information, including change in tumor resistance during ablation and slope of the resistance curve, were used to evaluate effectiveness of tumor ablation in terms of local failure or recurrence (LFR) and disease-free survival (DFS). Results A total of 65 patients underwent IRE for locally advanced pancreatic cancer. Median follow-up was 23 months. Local failure or recurrence was seen in 17 patients at 3, 6, or 9 months post IRE. Change in tumor tissue resistance and the slope of the resistance curve were both significant in predicting LFR (p = 0.02 and p = 0.01, respectively). The median local disease-free survival was 5.5 months in patients who had recurrence compared with 12.6 months in patients who did not recur (p = 0.03). Neither mean change in tumor tissue resistance nor the slope of the resistance curve significantly predicted overall DFS. Conclusions Mean change in tumor tissue resistance and the slope of the resistance curve could be used intraoperatively to assess successful tumor ablation during IRE. Larger sample size and longer follow-up are needed to determine if these parameters can be used to predict DFS.
OBJECTIVES:Ablative therapies have been increasingly utilized in the treatment of locally advanced pancreatic cancer (LAPC). Irreversible electroporation (IRE) is an energy delivery system, effective ...in ablating tumors by inducing irreversible membrane destruction of cells. We aimed to demonstrate efficacy of treatment with IRE as part of multimodal treatment of LAPC.
METHODS:From July 2010 to October 2014, patients with radiographic stage III LAPC were treated with IRE and monitored under a multicenter, prospective institutional review board–approved registry. Perioperative 90-day outcomes, local failure, and overall survival were recorded.
RESULTS:A total of 200 patients with LAPC underwent IRE alone (n = 150) or pancreatic resection plus IRE for margin enhancement (n = 50). All patients underwent induction chemotherapy, and 52% received chemoradiation therapy as well for a median of 6 months (range, 5–13 months) before IRE. IRE was successfully performed in all patients. Thirty-seven percent of patients sustained complications, with a median grade of 2 (range, 1–5). Median length of stay was 6 days (range, 4–36 days). With a median follow-up of 29 months, 6 patients (3%) have experienced local recurrence. Median overall survival was 24.9 months (range4.9–85 months).
CONCLUSIONS:For patients with LAPC (stage III), the addition of IRE to conventional chemotherapy and radiation therapy results in substantially prolonged survival compared with historical controls. These results suggest that ablative control of the primary tumor may prolong survival.
Irreversible electroporation (IRE) is a novel technology that uses peri-target discrete probes to deliver high-voltage localized electric current to induce cell death without thermal-induced ...coagulative necrosis. "Learnability" and consistently effective results by novice practitioners is essential for determining acceptance of novel techniques. This multi-center prospectively-collected database study evaluates the learning curve of IRE.
Analysis of 150 consecutive patients over 7 institutions from 9/2010-7/2012 was performed with patients treated divided into 3 groups A (1(st) 50 patients treated), B (2(nd) 50) and C (3(rd) 50 patients treated) chronologically and analyzed for outcomes.
A total of 167 IRE procedures were performed, with a majority being liver(39.5%) and pancreatic(35.5%) lesions. The three groups were similar with respect to co-morbidities and demographics. Group C had larger lesions (3.9 vs 3 cm,p=0.001), more numerous lesions (3.2 vs 2.2,p=0.07), more vascular invasion(p=0.001), underwent more associated procedures(p=0.001) and had longer operative times(p<0.001). Despite this, they had similar complication and high-grade complication rates(p=0.24). Attributable morbidity rate was 13.3%(total 29.3%) and high-grade complications were seen in 4.19%(total 12.6%). Pancreatic lesions(p=0.001) and laparotomy(p=0.001) were associated with complications.
The review represents that single largest review of IRE soft tissue ablation demonstrating initial patient selection and safety. Over time, complex treatments of larger lesions and lesions with greater vascular involvement were performed without a significant increase in adverse effects or impact on local relapse free survival. This evolution demonstrates the safety profile of IRE and speed of graduation to more complex lesions, which was greater than 5 cases by institution. IRE is a safe and effective alternative to conventional ablation with a demonstrable learning curve of at least 5 cases to become proficient.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Background
Several contemporary risk stratification tools are now being used since the development of the Charlson Comorbidity Index (CCI) in 1987. The purpose of this systematic review and ...meta-analysis was to compare the utility of commonly used co-morbidity indices in predicting surgical outcomes.
Methods
A comprehensive review was performed to identify studies reporting an association between a pre-operative co-morbidity measurement and an outcome (30-day/in-hospital morbidity/mortality, 90-day morbidity/mortality, and severe complications). Meta-analysis was performed on the pooled data.
Results
A total of 111 included studies were included with a total cohort size 25,011,834 patients. The studies reporting the 5-item Modified Frailty Index (mFI-5) demonstrated a statistical association with an increase in the odds of in-hospital/30-day mortality (OR:1.97,95%CI: 1.55–2.49,
p
< 0.01). The pooled CCI results demonstrated an increase in the odds for in-hospital/30-day mortality (OR:1.44,95%CI: 1.27–1.64,
p
< 0.01). Pooled results for co-morbidity indices utilizing a scale-based continuous predictor were significantly associated with an increase in the odds of in-hospital/30-day morbidity (OR:1.32, 95% CI: 1.20–1.46,
p
< 0.01). On pooled analysis, the categorical results showed a higher odd for in-hospital/30-day morbidity (OR:1.74,95% CI: 1.50–2.02,
p
< 0.01). The mFI-5 was significantly associated with severe complications (Clavien-Dindo ≥ III) (OR:3.31,95% CI:1.13–9.67,
p
< 0.04). Pooled results for CCI showed a positive trend toward severe complications but were not significant.
Conclusion
The contemporary frailty-based index, mFI-5, outperformed the CCI in predicting short-term mortality and severe complications post-surgically. Risk stratification instruments that include a measure of frailty may be more predictive of surgical outcomes compared to traditional indices like the CCI.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
Abstract Background Pancreatic cancer is the 4th leading cause of cancer death in the United States. A screening protocol is needed to catch early-stage, resectable disease. This study suggests a ...protocol for high-risk individuals and assesses the cost in the context of the Affordable Care Act. Methods Medicare and national average pricing were used for cost analysis of a protocol using magnetic resonance imaging/MRCP biannually in high-risk groups. Results Costs per year of life added” based on Medicare and national average costs, respectively, are as follows: $638.62 and $2,542.37 for Peutz–Jeghers syndrome, $945.33 and $3,763.44 for hereditary pancreatitis, $1,141.77 and $4,545.45 for familial pancreatic cancer and “p16-Leiden” mutations, and $356.42 and $1,418.92 for new-onset diabetes over age 50 with weight loss or smoking. Conclusions A screening program using magnetic resonance imaging/MRCP is affordable in high-risk populations. The United States Preventive Services Task Force must re-evaluate its pancreatic cancer screening guidelines to make screening more cost-effective for the individual.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Current depictions of autonomous vehicle (AV) futures are produced primarily by automobile manufacturers that largely reflect and reinforce existing sociotechnical systems in a ‘business as usual’ ...model that frames this technology within a narrative of crisis and technological salvation. This article argues for a more complex analysis of AV futures in which images are understood as vessels for sociotechnical imaginaries that direct and delimit what we think is possible in the future. Through an analytical framework incorporating automobility, transitions, and imaginaries, I explore how depictions of AVs frame the technology as responding to various system pressures over time through a comparative analysis of two actors. The analysis suggests that regime actors deploy visual discursive material as a tool of regime stability or change to benefit their own agendas. The intention of the article is not to anticipate current trajectories but is a methodological exploration of how policymakers and planners can interpret AV visualisations. Therefore, the paper concludes with a discussion of the implications of these imaginaries for future transportation systems. It further suggests that policymakers and planners need to take a more active role in the development of AV futures by paying much more attention to the latent meanings behind AV visualisations and working collaboratively with those who produce them.
Background
This study was designed to evaluate the safety, efficiency, effectiveness, and overall long-term outcome in patients treated with microwave thermal ablation of hepatic tumors. Microwave ...ablation technology represents the next generation in ablative techniques for the treatment of hepatic malignancies. Currently there have been no large reports of its use in the United States with appropriate long-term follow-up.
Methods
An institutional review board-approved prospective phase II study of microwave ablation of hepatic malignancies from January 2004 to January 2009 was performed. All complications were recorded up to 90 days from operation and reported using an established five-point grading scale.
Results
One hundred patients underwent 270 ablations for hepatic malignancies. The most tumor types were as follows: metastatic colorectal cancer (50%), hepatocellular carcinoma (17%), metastatic carcinoid (11%), and other metastatic disease (22%). A majority of patents (53%) underwent combination hepatic resection and microwave ablation; 38% underwent ablation alone, 9% underwent ablation and additional organ resection, with 68% open procedures. Median tumor size was 3.0 (range, 0.6–6.0) cm, median number of tumors was 2 (range, 1–18), and median total ablation time was 13 (range, 5–45) min. Overall 90-day mortality was 0% and morbidity was 29%. One patient developed a hepatic abscess and no patients experienced bleeding complications. After a median follow-up of 36 months, 5 patients (5%) had incomplete ablation, 2 (2%) had local recurrence at the ablated site, and 37 (37%) developed intrahepatic recurrence at nonablated sites.
Conclusions
Microwave ablation of hepatic tumors is a safe and effective method for treating unresectable hepatic tumors, with a low rate of local recurrence.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
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