Neutral argon plasma vaporization shows little damage to normal tissue and allows a complete removal of tumor tissue, that is, without leaving any cell debris viable tumor. Our primary objective is to evaluate the effectiveness and safety of neutral argon plasma on peritoneal implants with different dosimetry in vivo and ex vivo.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
10
Evaluation of the mesentery or peritoneum area infiltrated by miliary implants that is going to be treated. Determination of the PCI. Collection of several samples of the mesenteric peritoneum or parietal peritoneum with tumor involvement (implants between 1-2.5mm of diameter). It will established a matrix which will be divided into 12 quadrants where the tissue with implants will be placed and it will be treated according to specific power (80-100%), and for an action time of 2-4 seconds or until macroscopic tumor destruction. For each power, application of Plasmajet at 1, 2 and 3 cm from the target tumor tissue. The in-vivo effect will be evaluated with the use of ball-tip in terms of damage to the serosa or vascularization of the mesentery.
University Hospital Reina Sofia
Córdoba, Spain
Pathological evaluation
Pathological evaluation, in the Pathological Anatomy service of the University Hospital Reina Sofía, of both samples of peritoneum and evaluation of the presence of cells tumors and degree of tissue destruction, after performing the procedure according to the indications of the "Interventions" section. The specimens will be fixed in formaldehyde for about 48 hours and cut and fixed in paraffin. They will be stained with hematoxylin and eosin according to protocol, after being cut in the area of greatest macroscopic lesion produced by the device. It will be used microscopy and optical micrometer to measure the depth of vaporization of the tissue, as well as damage to adjacent healthy tissue. Depth is measured from a line parallel to the surrounding tissue to the point deeper tissue evaporation. As all quadrants will include tumor implants, they will also have flat tissue without tumor and it will be which the depth is measured from.
Time frame: Through study completion, an average of 1 year.
Evaluation of mesentery vascular damage and damage to the intestinal serosa.
Evaluation of mesentery vascular damage and damage to the intestinal serosa. It will be evaluated in-vivo and it will be analyzed by a third party on video.
Time frame: During the surgery and through study completion, an average of 1 year.
Morbidity associated with treatment.
Evaluation of morbidity associated with treatment. Using CTCAE scale v4.0 30 days after the intervention. We will pay special attention to events associated with hemoperitoneum, intestinal fistulas or intestinal perforations.
Time frame: 30 days after the intervention
Mortality associated with treatment.
Evaluation of mortality associated with treatment. Using CTCAE scale v4.0 30 days after the intervention. We will pay special attention to events associated with hemoperitoneum, intestinal fistulas or intestinal perforations.
Time frame: 30 days after the intervention
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Global morbidity.
Evaluation of global morbidity using CTCAE v 4.0 scale.
Time frame: Within the 30 days post-intervention
Global mortality.
Evaluation of global mortality using CTCAE v 4.0 scale.
Time frame: Within the 30 days post-intervention