2015年12月16日星期三

The First Nano Knife (irreversible electroporation) Treatment for Cancer in Mainland of China Completed in Guangzhou

In the morning of July 1, 2015, a special operation was undergoing in the operation room of Guangzhou Fuda Cancer Hospital. The patient lying on the operation table was a 61-year-old man from Middle East. With the assistance of renowned abdominal surgeon--Prof. Li Chaolong, Dr. Niu Lizhi cut open the patient’s upper abdominal with adept skill, separated stomach and intestinal canal to expose pancreas. A 4.5x5.0cm large quasi circular mass is found. Dr. Niu put the ultrasonic surgical probe on the mass and an uneven high- density echo displayed on the ultrasound screen. Under the guidance of ultrasound image, Dr. Niu placed a special electrode needle (called main needle) into one side of the mass and inserted its tip to the bottom of the mass; then two auxiliary electrode needles were inserted into the other side and the center of the mass separately. The three needles formed a tripod shape with the distance between each standing at 2cm.

Beside the operating table, an engineer was adjusting the medical equipment called “NanoKnife.” On the screen displayed flashing electric pulse, which meant that the equipment was at operational readiness. Beneath the NanoKnife was a special electrocardiogram equipment, which displayed the patient’s cardiac rhythm.

 
During operation      
                                                                              
The treatment started. Dr. Niu ordered: electric shock. According to the premeditated plan, three groups of electric shocks with 1500V voltage and 70 microseconds pulse length are administered with 90 pulses in each group. With the pulses pushing in, the ultrasound screen displayed that the original high-density echo of the tumor was getting lower.

After the above-mentioned procedures were done, Dr. Niu changed the position of two auxiliary electrode needles and electric pulses were administered again. Then, three electrode needles were pulled up and electric pulses were administered again. After repeating the process for five times, the tumor had fully received electric pulses. The CT scan (contrast agent enhancement) on the second day showed whole tumor necrosis.

This is a memorable moment. On this day, FUDA succeed in treating pancreatic cancer by adopting the world’s latest ablation technology--irreversible electroporation for the first time in Guangzhou, also in China. The technology got its name “Nano Knife” because it would make nanoscale membrane perforation in targeted tissue or cells.

As a significant progress in tumor treatment of the 21st century, tumor ablation has presented an effective treatment and even radical chance for patients with unresectable tumor or patients who cannot tolerate operation. The most frequently used technologies include thermal ablation (radio-frequency and microray) and cryoablation (Argon-Helium Knife and liquid nitrogen). Nano Knife is a special ablation technology belonging to neither thermal ablation nor cryoablation. If ablation could be compared to the “crown “of local treatment for cancer, then Nano Knife could be compared to the “pearl” on the “crown”. The basic rationale of Nano Knife is that ablation probes release microsecond high voltage pulse that breaks tumor cell membrane so as to form nanoscale irreversible electroporation and finally kill targeted cells (cancer cells).

Nano Knife electrode needles

A series of experiments and clinical research indicate that compared with other ablation technologies, Nano Knife has the following unique advantages: the ablation of tissue is selective. The ablation destroys only cells and does no harm to vascular wall, nerve, trachea, bronchus, gallbladder, intestinal canal, and ureter; boundaries of ablation area is clear, which is extremely important for small volume pancreas; ablation does not generate energy nor rely on it, and it is not influenced by the blood flow of adjacent big vessels, such as celiac artery and aorta; the death of cells is not necrosis but apoptosis, which could stimulate anticancer immune responses; the ablation requires short treatment time. It just takes 5 minutes to ablate 3.0 cm large tumor and anesthesia time will also shorten accordingly, which is conducive to postoperative recovery. The ablation process can be clearly displayed on ultrasound, CT or MR, thus ensuring the maximal effect of ablation.

Developed and manufactured by America AngiDymanics company, Nano Knife was approved by America FDA for “soft tissue tumor ablation”, which was hailed by experts around the world. European Union, Australia, Canada has also successively approved Nano Knife for application. As of today, over 100 key tumor hospitals have adopted this technology in treating more than 6,000 cases. Treated tumors are located in pancreas, lungs, kidney, prostate, and other parenchymal organs as well as in soft tissues. It is especially applicable to tumors near big vessels, hepatic hilum, gallbladder, bile ducts, and ureter. According to literature, Nano Knife is of great value in treating pancreatic cancer.

Nano Knife can not only be applied to surgery, such as laparotomy. Electrodes needles can also be inserted into tumor through puncture point and percutaneous ablation can be administered under the guidance of CT or ultrasound. In recent days, under the guidance of CT and ultrasound, doctors in FUDA have carried out percutaneous Nano Knife ablation on a postoperative gastric cancer metastasis and a pancreatic head tumor.

In June, 2015, China approved Nano Knife for tumor treatment. In order to apply Nano Knife into clinical treatment in an early date, one year before it is approved by China, Dr. Niu Lizhi has led experts and relevant medical workers to study stacks of literature and arranged several study tours in America. They compiled the first monograph about Nano Knife in China, New Technique of Cancer Ablation: Irreversible Electroporation published by Shanghai Science and Technology Literature in 2014. In cooperation with overseas institutions, experts and medical workers in FUDA carried out a large number of Nano Knife ablation experiments on animals, studied its influence and safety on such key structures as nerves, vessels, bile ducts and ureter and published the first paper about Nano Knife in China on  Journal of Interventional Radiology.

Before Treatment

After Treatment

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