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

Not Applicable

Completed

• Conditions: Peritoneal Carcinomatosis
• Interventions: Device: Use of plasma of neutral argon

• Registration Number: NCT04904042
• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-18
• Study First Submitted QC: 2021-05-21
• Study First Posted: 2021-05-27
• Study Start: 2021-06-01
• Primary Completion: 2022-04-03
• Status Verified: 2022-05
• Study Completion: 2022-05-03
• Last Update Submitted: 2022-05-30
• Last Update Posted: 2022-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Use of plasma of neutral argon	Use of plasma of neutral argon	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.

Primary Outcome Measures

Name	Time	Method
Pathological evaluation	Through study completion, an average of 1 year.	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.

Secondary Outcome Measures

Name	Time	Method
Morbidity associated with treatment.	30 days after the intervention	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.
Global mortality.	Within the 30 days post-intervention	Evaluation of global mortality using CTCAE v 4.0 scale.
Evaluation of mesentery vascular damage and damage to the intestinal serosa.	During the surgery and through study completion, an average of 1 year.	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.
Mortality associated with treatment.	30 days after the intervention	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.
Global morbidity.	Within the 30 days post-intervention	Evaluation of global morbidity using CTCAE v 4.0 scale.

Trial Locations

Locations (1)

University Hospital Reina Sofia; 🇪🇸 Cordoba, Spain