National Taiwan University Hospital has completed clinical trials for a Nanoknife procedure, or irreversible electroporation (IRE), on malignant liver tumors, confirming the technology’s therapeutic safety and efficacy, the hospital said yesterday.
Liver cancer is difficult to treat and is one of the most common and deadliest cancers in the country, with over 10,000 new cases diagnosed and more than 8,000 deaths from the disease each year.
“The techniques used in traditional surgery, such as resection and ablation, may cause damage to blood vessels or other organs that are close to the tumor to be removed, and thus may not be performed on certain patients who have tumors located in dangerous areas,” said Huang Kai-wen (黃凱文), an attending physician specializing in tumor surgery at the hospital’s Hepatitis Research Center.
“They would then have to resort to chemotherapy, radiotherapy or other alternative therapies with relatively compromised efficacy,” he added.
“The new medical technology, using high voltage electrical pulses to create permanent and lethal nanopores in the membrane of the cancer cells, a process called irreversible electroporation, holds promise for those patients, with its precision for sparing the surrounding healthy tissue,” Huang said.
The procedure involves the insertion of electrode needles through the skin into the tumor, and the creation of an electric field around the lesion and microscopic holes in the cell membranes of the cancer cells.
The hospital started animal experiments in 2010, when the US and Europe started to perform IRE clinically, and began clinical trials of the minimally invasive technique IRE using the Nanoknife system in 2012, the hospital said.
Huang said that the hospital last November completed the first stage of the clinical trials, which focused on liver cancer, approved by the Ministry of Health and Welfare.
The medical team has since the beginning of the clinical trial successfully performed IRE via percutaneous, laparoscopic and open surgical approaches, and has started to develop use of the technique on other difficult malignancies such as metastatic colorectal cancer, pancreas cancer and cholangiocarcinoma.
“None of the recruited patients died during surgery or post-surgery, with those who had undergone percutaneous IRE able to be discharged a day after the treatment,” Huang said.
“A total of 41 patients have been followed for average of a year,” he said, adding that most of the patients with liver cancer have not experienced recurrence and are still alive today, with few cases developing tumors in other lobes of the liver.
The hospital is among the three authorized clinical training centers for the treatment in the world and the only one in the Asia-Pacific region, the hospital said, with past participating physicians from Japan, Australia, China, Hong Kong and other Asian countries.