The technique has received Food & Drug Administration 501(k) medical device approval for use in soft tissue, and is considered “off label” for use on organs, he said.
“What we have established is the safety and the ability to treat pancreatic cancer without surgery, and early results are promising,” Narayanan said. “But we really have to conduct a trial to establish the complete potential of this technology.”
Aside from the Nanoknife, about 20 percent of pancreatic cancer patients may be candidates for a complex surgical procedure called the Whipple procedure.
The five-to six-hour operation involves removing the “head’’ of the pancreas, (an area involved in the vast majority of pancreatic cancers), the duodenum and the gallbladder, said surgical oncologist Dr. Omar Llaguna, who has performed at least 25 Whipple procedures since joining Baptist Health Medical Group last July.
“It’s such a tight quarters where the head of the pancreas is, that you can’t just take it out. You have to take out the adjacent quarters,” he said.
Then, the surgeon must make several reconnections of the remaining organs.
“The best outcome is always in someone who can undergo resection, recover, and then go on to complete their chemotherapy,” Llaguna said.
Meanwhile, a clinical trial of a novel chemotherapy drug for advanced pancreatic cancer is underway nationwide, and being done at Mount Sinai Medical Center in Miami Beach.
The hospital is still enrolling patients who have been newly diagnosed with Stage IV, metastatic pancreatic cancer, and have received no prior chemotherapy. The trial is randomized, so one-third of patients will receive regular chemotherapy instead of the new drug, said Dr. Mike Cusnir, an oncologist at Mount Sinai Comprehensive Cancer Center.
The study is examining a promising new drug, ON 01910.Na.
“What is important is that it’s a drug that has a fairly novel mechanism of action — it works in a different pathway than has been done in the past,” Cusnir said.
The drug damages the division of cells, so hopefully they cannot divide, he said.
“Research offers hope,” Cusnir said. “So anytime we have a research over the standard of care, it offers hope.”