1. General Information - IRE NanoKnife

a) Expected results, benefits

NanoKnife is a high innovative solution for cancer treatment. It can be used in Patients who suffer from tumours located in organs which exclude other surgical methods as the risk of the vital anatomical structures violation is too high, such as the pancreas, kidney, liver or prostate. NanoKnife hits the tumour precisely. Owing to this method no adjacent organ/tissue could be damaged, as it happens in other cancer treatments. It is also useful in the treatment of difficult relapse or incomplete surgery of tumours of lymph nodes, colorectal cancer, stomach cancer or cholangiocarcinoma. There are great advantages of using the NanoKnife method:

  • Expansion of treatment options in Patients who cannot be candidates for traditional surgery because of the location of the cancer change,
  • Extension of the traditional chemo treatment, as a direct treatment hitting carcinomas outbreaks.
  • Possibility to perform the procedure transdermally – without surgery,
  • Shorter stay in the clinic,
  • Procedure is mostly painless,
  • The procedure does not cause hair loss.
  • No thermal effect could influence negatively other tissues,
  • Ability to repeat the procedure in the case of tumour recurrence;
  • Real-time ablation screening under USG or CT.
  • IRE therapy in prostate cancer does not cause side effects like impotence; it does not affect urethra.
  • It does not destroy collagen scaffold structure
  • It retains the structure of nerve sheaths.
  • The tissues reparation process lasts shorter than two weeks
  • The destroyed tissues are absorbed by the body during several weeks

b) About the procedure

The NanoKnife ® method is considered as one of the most innovative solutions in the field of oncologic treatment, and as the tumours surgery future. It is a new alternative to chemotherapy, radiotherapy and other surgical- and minimally invasive ablative treatments.
It is a first tumour (cancer) cells resection system operating by irreversible electroporation – IRE. NanoKnife IRE is the first advanced medical device using the non-thermal ablation (destruction) enabling to destroy cancerous tissues located in non-operable places – the location of changes in proximity to vital anatomical structures, with an outstanding accuracy and in a very efficient way.
The characteristic feature of Nanoknife is a huge precision of the device using pulsing electric field with power 1500 up to 3000 V.
The NanoKnife System has received FDA clearance for the procedure of surgical ablation of soft issues. It has not received clearance for any specific therapy, but there are may clinical trials ongoing to prove its efficacy. It has been already approved in 45 countries – Canada, China, Australia and the European Union. It has also won the approval in South Korea, which offers further evidence of the incredible value that this system can offer patients worldwide. There are some previous methods where reversible electroporation was used in conjunction with chemo drugs in cancer treatment, but the results were temporary. IRE (Irreversible electroporation) is targeted in the cancer tissues and the energy level, as well as duration, causes cell death which makes the NanoKnife device a new hope and a future of cancer treatment.

c) Treatment Schedule

The procedure is carried out under general anaesthesia, and it requires the muscles lock. In the non-surgical option which is used, for example, in the prostate cancer treatment, two up to 6 electrodes are applied to the subcutaneous tumour. The tumour is surrounded by an electrical field which eventually leads to the irreversible electroporation effect – the damage of cancer cells. Blood vessels and nerves are not harmfully affected. Sometimes there is a need of the surgical intervention to get to the tumour, then the second part of the procedure is equal. As a result of apoptosis of the tumour cells, dead cells are removed by macrophages. By 14 days after the procedure, the tissues are regenerated. No space – Lodge – is left after this treatment, and the regeneration is very quick.

d) Potential side effects

As this method of cancer treatment is very innovative and new (since 2011) the long-term side effects are unknown. The irreversible electroporation treatment is addressed directly into the tumour, side effects alike other similar methods do not appear – there is no risk of affecting adherent tissues. In some cases, where no other treatment such as chemotherapy or surgical intervention is permissible, the NanoKnife IRE treatment could be the only chance for Patients.
Irreversible Electroporation as a method has received FDA clearance for the surgical ablation of soft tissue. FDA is a Food and Drug Administration governmental American institution known for it’s strict and rigorous approach. However, it still misses the FDA clearance certificate in cancer treatment indication, as no randomised clinical trial studies with evaluation had been finished – there are some running, and the end date is predicted on 2018. Although the producer company intends to pursue FDA approval in the field of cancer treatment, the time frame for a regulatory submission is not yet known. As the device is approved for surgical ablation, off-label use for cancer treatment takes place, as NanoKnife offers a non-invasive alternative to chemotherapy, radiation therapy, and surgical and minimally invasive ablative treatments. This method also owes a European CE certificate.

e) Full Recovery Time

Please note that in the treatment of cancer, no medical procedure guarantees a 100% effective outcome. This is due to a complexity of human body, individual features as well as many other factors, which influence the final result we cannot predict. In many cases, the IRE method is considered as the best and repeatedly the only possible treatment. The final results differs when it comes to tumour location, prior treatment (if the body is highly exhausted by many chemo series). We recommend to consult with your Doctor the possibility of NanoKnife therapy at the very beginning of treatment and right after diagnosis. After NanoKnife treatment after 7 days you are ready to travel, and after 2 weeks the tissues are totally regenerated.

2. Patient’s preparation

Before undergoing a NanoKnife procedure the Patient needs to have all of diagnostics imagine done. USG, X-Ray, CT, MR, bone scintigraphy, PET, blood tests and EKG. When it comes to prostate cancer treatment before IRE procedure sometimes also a crotch saturation biopsy (mapping) should be undergone, because it allows to define precisely the locations of tumors. We encourage to consult the plan of treatment with more than one specialist.

3. Diagnostics

Diagnosis of cancer tumours is complex and detailed. Probably if you have some conjectures about your bad health condition first, you will visit your GP. After medical examinations, you will be directed to the oncology clinic. There are many methods to diagnose cancer – biopsy, Needle Aspiration, ultrasonography, X-Ray, extensive blood tests with an indication of tumour markers or PET scan. Please note that each type of cancer is diagnosed differently. Note that you only will be included in the NanoKnife treatment when you meet the criteria of qualification (including the ability to undergo general anaesthesia, former treatment, available metastasis and more).

4. Qualification for the NanoKnife procedure

The Doctor conducts the qualification to the NanoKnife procedure basing on the Patient’s medical record, interview, detailed examination and diagnostics – Magnetic Resonance, Computer Tomography, Biopsy, bone scintigraphy. Note that you only will be included in the NanoKnife treatment when you meet the criteria of qualification (including the ability to undergo general anaesthesia, former treatment, available metastasis and more).

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About the NanoKnife soft tissues ablation procedure.

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