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The purpose of this study is to evaluate the short and intermediate term outcomes of the NanoKnife Irreversible Electroporation System when used to treat unresectable pancreatic cancer. In addition, the study will evaluate the efficacy of this device in treating symptoms of unresectable pancreatic cancer. The NanoKnife, System has been commercially available since 2009, and is FDA-approved to treat soft tissue tumors. The NanoKnife System has received FDA clearance for the surgical ablation of soft tissue. It has not received clearance for the therapy or treatment of any specific disease or condition.
Irreversible electroporation (IRE) has the potential to dramatically widen the treatment options for patients with pancreatic cancer. It provides a minimally invasive procedure that could potentially avoid radical surgery for smaller lesions, and it could potentially offer palliation of symptoms such as pain, gastric outlet obstruction and jaundice in patients with locally advanced unresectable disease.
The prognosis for pancreatic cancer is dismal, with a five-year survival rate of 4.9%. Current treatment options include surgical resection, chemotherapy and radiation. Only 15% percent of pancreatic cancers are considered resectable at the time of diagnosis. Current chemotherapeutic options are limited, as pancreatic adenocarcinoma is poorly responsive to chemotherapy. Radiofrequency ablation of the pancreas in the setting of locally advanced unresectable disease has been described in a few case series1-6, but implementation of that technology is limited by concerns over thermal injury to adjacent organs and vessels. With 42,470 new cases of pancreatic cancer diagnosed annually in the US and given that pancreatic cancer is expected to claim 35,240 lives this year in the US7, it is the fourth leading cause of cancer death in the Unites States. This information supports the notion that there is an unquestionable need for novel therapeutic strategies for the treatment of this disease.
Irreversible electroporation (IRE) has the potential to dramatically widen the treatment options for patients with pancreatic cancer. It provides a minimally invasive procedure that could potentially avoid radical surgery for smaller lesions, and it could potentially offer palliation of symptoms such as pain, gastric outlet obstruction and jaundice in patients with locally advanced unresectable disease. Preliminary studies of IRE in the liver and prostate have demonstrated that structures such as bile ducts, ejaculatory ducts, neurovascular bundles, blood vessels, and the urethra heal normally after ablation, suggesting that vessels and ducts within and around the pancreas may also be heal normally. Collagen matrix during treatment with IRE is not destroyed thus allowing for a structure to heal normally. There is no evidence that nerve ganglion are damaged.
Heat based ablative therapy in the pancreas has the potential for unique complications. Pancreatic necrosis is believed to play a role in creating a potentially life-threatening systemic inflammatory response in patients with severe acute pancreatitis8, 9 and the presence of free active pancreatic enzymes is believed to contribute to the inflammatory cascade of acute pancreatitis. Irreversible electroporation could potentially cause both pancreatic necrosis and the release of active pancreatic enzymes. Additionally, the pancreas surrounds or abuts several vital structures, including the common bile duct, the pancreatic duct, the superior mesenteric artery and vein (SMA and SMV), the portal vein, the stomach, and the duodenum. IRE as a non-thermic ablative modality has the potential to achieve pancreatic ablation with respect of the surrounding vascular and ductal structures.
Electroporation is a technique that increases cell membrane permeability by momentarily changing the transmembrane potential and subsequently disrupting the lipid bi-layer integrity to allow transportation of molecules across the cell membrane via nano-size pores. This process - when used in a reversible fashion - has been used in research for drug or gene delivery into cells.
Irreversible electroporation (IRE) is a method to induce irreversible disruption of cell membrane integrity (loss of cell homeostasis) resulting in cell death without the need for additional pharmacological injury. Because IRE is a non-thermal technique, changes associated with perfusion-mediated tissue cooling (or heating) are not relevant. While cells in the ablation region are destroyed, the underlying extracellular matrix is not damaged thus allowing tissues in the ablation zone to heal normally.
IRE is administered under general anesthesia with administration of atracurium, cis-atracurium, pancuronium or an equivalent neuromuscular blocking agent. This is mandatory to prevent undesirable muscle contraction.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Unresectable Pancreatic Cancer
NanoKnife IRE System
University of Maryland Medical Center
University of Maryland
Published on BioPortfolio: 2014-09-30T16:38:22-0400
This I/II study will evaluate to see how safe and useful irreversible electroporation (also called NanoKnife) is in patients with locally advanced pancreatic cancer.
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Tumors or cancer of the PANCREAS. Depending on the types of ISLET CELLS present in the tumors, various hormones can be secreted: GLUCAGON from PANCREATIC ALPHA CELLS; INSULIN from PANCREATIC BETA CELLS; and SOMATOSTATIN from the SOMATOSTATIN-SECRETING CELLS. Most are malignant except the insulin-producing tumors (INSULINOMA).
Star-shaped, myofibroblast-like cells located in the periacinar, perivascular, and periductal regions of the EXOCRINE PANCREAS. They play a key role in the pathobiology of FIBROSIS; PANCREATITIS; and PANCREATIC CANCER.
A cancer registry mandated under the National Cancer Act of 1971 to operate and maintain a population-based cancer reporting system, reporting periodically estimates of cancer incidence and mortality in the United States. The Surveillance, Epidemiology, and End Results (SEER) Program is a continuing project of the National Cancer Institute of the National Institutes of Health. Among its goals, in addition to assembling and reporting cancer statistics, are the monitoring of annual cancer incident trends and the promoting of studies designed to identify factors amenable to cancer control interventions. (From National Cancer Institute, NIH Publication No. 91-3074, October 1990)
A 36-amino acid pancreatic hormone that is secreted mainly by endocrine cells found at the periphery of the ISLETS OF LANGERHANS and adjacent to cells containing SOMATOSTATIN and GLUCAGON. Pancreatic polypeptide (PP), when administered peripherally, can suppress gastric secretion, gastric emptying, pancreatic enzyme secretion, and appetite. A lack of pancreatic polypeptide (PP) has been associated with OBESITY in rats and mice.
Extracts prepared from pancreatic tissue that may contain the pancreatic enzymes or other specific uncharacterized factors or proteins with specific activities. PANCREATIN is a specific extract containing digestive enzymes and used to treat pancreatic insufficiency.
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