Side Effects - IGEA Cliniporator EPS02 User Manual

Warnings
When the electroporation is associated to the delivery of drugs, refer to the specific
documentation related to the used drugs.
The delivery of impulses can be associated with strong muscular contractions, therefore it is
recommended to evaluate the use of an anesthesia with TOF (Train Of Four) = 0, especially in
the treatment of deep, visceral or open-skinned lesions.
When treating lesions located in the head and neck area, it is recommended to:
- Consider using intraoperative imaging (i.e. echography) to avoid involuntary involvement of
important structures.
- Carefully consider treating the rear part of the tongue and the hypopharynx.
Electrochemotherapy might induce bleeding and tissue necrosis and cause adverse events
to the patient.
- Define a precise strategy for post-treatment pain management, especially for the treatment
of mucosa and tongue since the pain will be stronger in comparison to the normal cutaneous
application.
In case of visceral opencast treatments, it is recommended the use of cardiac synchronisation
(sec. 5.7) to avoid interferences with the electrical activity of the heart.
Pre-existing pathologies or concurrent pharmacological therapies - which lower the fibrillation
threshold - might increase the risk that the treatment - especially if applied in the precordial area
or in proximity of the heart - might provoke cardiac fibrillation (atrial or ventricular) or other
arrhythmias.
In case of lesions near implanted metal parts, consider that the electric field delivered might be
subject to change. It is also necessary to avoid any contact between electrodes and metal parts.
In case of lesions located close to breast implants, pay attention to the contact between pointed
electrodes and implants.

3.4 Side Effects

Side effects of treatments based on high voltage pulses are reported in literature. Side effects
may be related to the application of high voltage pulses or drugs and chemicals used together
with the pulses. Side effects include:

Involuntary muscle contraction at the time of the electric pulse, which stops immediately
when the pulse train ends.
The contraction of the muscle is painful. The painful muscular contraction can be managed
by following the anaesthetic procedures indicated by the S.O.P. (see reference 8. of section
3.5).

Slight skin burns sometimes have been observed when employing plate electrodes.

Skin or mucosal exfoliation.

Osteomyelitis, dysphagia, pharyngocutaneous fistulas, wounds breakdown can be ascribed
to intravenous injection of bleomycin.
From: Cancer Treatment Reviews 2003. A Gothelf. LM Mir, J Gehl Electrochemotherapy:
Results of cancer treatment using enhanced delivery of bleomycin by electroporation.
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Cliniporator model EPS02 – User manual