Five Oral Presentations on Clinical Experience With NanoKnife® System Featured at Society of Interventional Radiology Conference
An oral presentation titled "A prospective, multicenter phase II
clinical trial using irreversible electroporation for the treatment of
early stage HCC," was given
The trial is a phase II prospective, multicenter clinical study to evaluate the efficacy and safety of the NanoKnife System as a first-line treatment for early-stage hepatocellular carcinoma (HCC), the most common form of liver cancer. It is registered with www.ClinicalTrials.gov as number NCT01078415.
The following retrospective data analyses also were presented at SIR's 2012 Annual Scientific Meeting.
An oral presentation titled "Downstaging locally advanced pancreatic
adenocarcinoma (LAPC) with vascular encasement using percutaneous
irreversible electroporation (IRE)," was given
Eight patients with biopsy-proven pancreatic cancer underwent
percutaneous ablation of pancreatic tumors using the NanoKnife System.
Imaging demonstrated intact veins in all patients' treatment zones
immediately, and 24-hours, after the procedure. Complications included
spontaneous pneumothorax during anesthesia in one case and pancreatitis
in one case. Both recovered completely. No mortalities occurred within
30 days. Follow up was conducted with each patient in the months after
the procedure. This analysis also was the subject of a press release
issued by SIR regarding the conference, as well as a press event hosted
by the organization on
An oral presentation titled "Vessel patency post Irreversible
Electroporation ablation — a 15 month follow up," was given
Ablation using the NanoKnife® System was performed in 79
procedures on 56 patients between
An oral presentation titled "Percutaneous Irreversible Electroporation
of Surgically Unresectable Pancreatic Carcinoma: Single Center Safety
Experience," was given
In this clinical experience, four consecutive patients with surgically unresectable pancreatic carcinoma received seven ablations of five tumors. No mortalities occurred within 30 days. No episodes of intra-operative arrhythmia occurred. Intra-operative transient hypertension occurred with all treatments. No patients had prolonged hypertension after completion of the procedure with the NanoKnife System. There were no incidents of hemorrhage, infection, pancreatic fistula, or bowel injury. One treatment was complicated by partial splenic infarction, which required no treatment. No patients required analgesics on discharge.
An oral presentation titled "Percutaneous irreversible electroporation
in the treatment of hepatocellular carcinoma (HCC) and metastatic
colorectal cancer (mCRC) to the liver," was given
Forty-nine patients underwent percutaneous ablation of unresectable HCC and mCRC liver tumors using the NanoKnife System. A total of 76 lesions were treated in 62 sessions. After a procedure with the system, 20 patients had a complete response, 19 had a partial response and one had stable disease as their best response. Two of the HCC patients were transplanted. The Kaplan-Meier estimated average progression free survival was 11.3 months for all patients, 11.6 for HCC patients, and 10.4 months for mCRC patients. Six patients experienced complications during the procedure of the following types: pneumothorax, pleural effusion and atrial flutter during anesthesia. All patients recovered fully from these complications. One patient died within one month of a procedure with the NanoKnife System due to disease progression.
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