Study of Safety and Efficiency of the Use of Neutral Argon Plasma in Cyto-reduction of Miliary Implants in the Peritoneal Surface. (Plasmajet)

Maimónides Biomedical Research Institute of Córdoba

Status: Completed

Conditions: Peritoneal Carcinomatosis

Treatments: Device: Use of plasma of neutral argon

Study type: Interventional

Funder types: Other

Identifiers

NCT04904042

FCO-PLASM-2020-01

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with peritoneal carcinomatosis (an attempt will be made to cover all histological types of carcinomatosis in similar distribution as 2 patients with carcinomatosis of colonic origin, 2 patients with carcinomatosis of ovarian origin, 2 patients with peritoneal pseudomyxoma, 2 patients with peritoneal mesothelioma and 2 patients with carcinomatosis of gastric origin) with PCI greater than 0 in regions 10-13, and that have been selected as candidates for cytoreductive surgery + HIPEC or for laparoscopy-laparotomy explorer (selection criteria established according to clinical practice usual), and that present peritoneal miliary dissemination consistent with the characteristics of this study for the tissue under examination (implants smaller than 0.25 cm, CC1).
• Signature of specific informed consent for participation in this study and to obtain biological samples.

Exclusion criteria

• Patients not suitable for CRS and HIPEC, according to the clinical criteria of the Surgery Unit Oncology and multidisciplinary committee.
• Refusal of the patient to participate in the study.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Use of plasma of neutral argon

Experimental group

Description:

Use of plasma of neutral argon in the eradication of tumor implants at the mesentery level, with different doses (established according to the percentage of energy used) and distances of application and time. It will also be compared in-vivo with control therapy of Monopolar electrofulguration at a power of 100 in cut mode with ball-tip terminal.

Treatment:

Device: Use of plasma of neutral argon