Ignite Creation Date:
2024-05-06 @ 2:26 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02041936
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-16
First Post:
2014-01-15
Brief Title:
Outcomes of Ablation of Unresectable Pancreatic Cancer Using the NanoKnife Irreversible Electroporation IRE System
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Evaluation of the Short and Intermediate Term Outcomes of Ablation of Locally Advanced Unresectable Pancreatic Cancer Using the NanoKnife Irreversible Electroporation IRE System - A Prospective Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
The prognosis for pancreatic cancer is dismal with a five-year survival rate of 49 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 42470 new cases of pancreatic cancer diagnosed annually in the US and given that pancreatic cancer is expected to claim 35240 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None