Ablation in Pancreatic Cancer: Past, Present and Future

The insidious onset and aggressive nature of pancreatic cancer contributes to the poor treatment response and high mortality of this devastating disease. While surgery, chemotherapy and radiation have contributed to improvements in overall survival, roughly 90% of those afflicted by this disease will die within 5 years of diagnosis. The developed ablative locoregional treatment modalities have demonstrated promise in terms of overall survival and quality of life. In this review, we discuss some of the recent studies demonstrating the safety and efficacy of ablative treatments in patients with locally advanced pancreatic cancer. Keywords: IRE; ablation; cryoablation; interventional; microwave; oncology; pancreatic cancer

Consensus Guidelines for the Definition of Time-to-Event End Points in Image-guided Tumor Ablation: Results of the SIO and DATECAN Initiative

There is currently no consensus regarding preferred clinical outcome measures following image-guided tumor ablation or clear definitions of oncologic end points. This consensus document proposes standardized definitions for a broad range of oncologic outcome measures with recommendations on how to uniformly document, analyze, and report outcomes. The initiative was coordinated by the Society of Interventional Oncology in collaboration with the Definition for the Assessment of Time-to-Event End Points in Cancer Trials, or DATECAN, group. According to predefined criteria, based on experience with clinical trials, an international panel of 62 experts convened. Recommendations were developed using the validated three-step modified Delphi consensus method. Consensus was reached on when to assess outcomes per patient, per session, or per tumor; on starting and ending time and survival time definitions; and on time-to-event end points. Although no consensus was reached on the preferred classification system to report complications, quality of life, and health economics issues, the panel did agree on using the most recent version of a validated patient-reported outcome questionnaire. This article provides a framework of key opinion leader recommendations with the intent to facilitate a clear interpretation of results and standardize worldwide communication. Widespread adoption will improve reproducibility, allow for accurate comparisons, and avoid misinterpretations in the field of interventional oncology research

Multicenter randomized controlled trial and registry study to assess the safety and efficacy of the NanoKnife® system for the ablation of stage 3 pancreatic adenocarcinoma: overview of study protocols

Background: Irreversible electroporation (IRE) is a local ablation technique utilizing high voltage, low energy direct current to create nanopores in cell membrane which disrupt homeostasis and leads to cell death. Previous reports have suggested IRE may have a role in treating borderline resectable and unresectable Stage 3 pancreatic tumors. Methods: Patients with Stage 3 pancreatic ductal adenocarcinoma (PDAC) will be enrolled in either a randomized, controlled, multicenter trial (RCT) or a multicenter registry study. Subjects enrolled in the RCT must have no evidence of disease progression after 3 months of modified FOLFIRINOX (mFOLFIRINOX) treatment prior to being randomization to either a control or IRE arm. Post-induction and post-IRE treatment for the control and IRE arms, respectively, will be left to the discretion of the treating physician. The RCT will enroll 528 subjects with 264 per arm and include up to 15 sites. All subjects will be followed for at least 24 months or until death. The registry study will include two cohorts of patients with Stage 3 PDAC, patients who received institutional standard of care (SOC) alone and those treated with IRE in addition to SOC. Both cohorts will be required to have undergone at least 3 months of SOC without progression prior to enrollment. The registry study will enroll 532 patients with 266 patients in each arm. All patients will be followed for at least 24 months or until death. The primary efficacy endpoint for both studies will be overall survival (OS). Co-primary safety endpoints will be 1) time from randomization or enrollment in the registry to death or new onset of Grade 4 adverse event (AE), and (2 high-grade complications defined as any AE or serious AE (SAE) with a CTCAE v5.0 grade of 3 or higher. Secondary endpoints will include progression-free survival, cancer-related pain, quality of life, and procedure-related pain for the IRE arm only

Ablation in pancreatic cancer: Past, present and future

The insidious onset and aggressive nature of pancreatic cancer contributes to the poor treatment response and high mortality of this devastating disease. While surgery, chemotherapy and radiation have contributed to improvements in overall survival, roughly 90% of those afflicted by this disease will die within 5 years of diagnosis. The developed ablative locoregional treatment modalities have demonstrated promise in terms of overall survival and quality of life. In this review, we discuss some of the recent studies demonstrating the safety and efficacy of ablative treatments in patients with locally advanced pancreatic cancer

Safety and Efficacy of Percutaneous Liver Microwave Ablation Using a Fully Water-Cooled Choke Ring Antenna: First Multicenter Clinical Report

Introduction: The safety and efficacy of a microwave ablation (MWA) system for the liver with novel technologies in field control, antenna cooling through the inner part of the choke ring, and dual temperature monitoring were evaluated in this multicenter retrospective study. Material and methods: Ablation characteristics and efficacy were assessed on follow-up imaging (computed tomography or magnetic resonance imaging). Safety was evaluated according to CTCAE classification. Results: Eighty-seven liver tumors (65 metastases and 22 hepatocellular carcinomas) measuring 17.8 ± 7.9 mm were treated in 68 patients. Ablation zones measured 35.6 ± 11 mm in longest diameter. The coefficients of variation of the longest and shortest ablation diameters were 30.1% and 26.4%, respectively. The mean sphericity index of the ablation zone was 0.78 ± 0.14. Seventy-one ablations (82%) had a sphericity index above 0.66. At 1 month, all tumors demonstrated complete ablation with margins of 0-5 mm, 5-10 mm, and greater than 10 mm achieved in 22%, 46%, and 31% of tumors, respectively. After a median follow-up of 10 months, local tumor control was achieved in 84.7% of treated tumors after a single ablation and in 86% after one patient received a second ablation. One grade 3 complication (stress ulcer) occurred, but was unrelated to the procedure. Ablation zone size and geometry in this clinical study were in accordance with previously reported in vivo preclinical findings. Conclusion: Promising results were reported for this MWA device. The high spherical index, reproducibility, and predictability of the resulting treatment zones translated to a high percentage of adequate safety margins, providing good local control rate

Endovascular management of renal transplant dysfunction secondary to hemodynamic effects related to ipsilateral femoral arteriovenous graft

Hemodialysis access options become complex in long-term treatment for patients with renal disease, while awaiting renal transplantation (RT). Once upper extremity sites are exhausted, lower extremities are used. RT is preferably in the contralateral iliac fossa, rarely ipsilateral. In current literature, RT dysfunction secondary to the hemodynamic effects of an ipsilateral femoral arteriovenous graft (AVG) has been rarely described. To our knowledge, AVG ligation is the only published technique for hemodynamic correction of an ipsilateral AVG. We present a simple, potentially reversible endovascular approach to manage the hemodynamic effects of an AVG, without potentially permanently losing future AVG access

Design principles for corporate venture transition processes in established technology firms

Corporate venturing has become a well known approach towards new business development and strategic renewal for established technology firms. However, without an effectively designed process for aligning and integrating a corporate venture in the established business, the firm increases the risk of venture failure. This paper provides a process perspective on corporate venture transition. Based on the results of an empirical study of six corporate venture transition processes we present suitable actions for each of the different phases of the venture transition process. In addition, we indicate the proper timing for venture transition, which is one of the long-standing difficulties in this area. Finally, we integrate the results of the empirical study with knowledge from extant literature in a set of design principles. These design principles provide practical guidelines to improve corporate venture transition processes