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

Phase I/II Study of Efficiency and Single-arm Safety on the Use of Neutral Argon Plasma in Cyto-reduction of Miliary Implants in the Peritoneal Surface.

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 Overview

• Status: Completed
• Conditions: Peritoneal Carcinomatosis
• Intervention / Treatment: Device: Use of plasma of neutral argon

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Cordoba, Spain, 14004
    • University Hospital Reina Sofía

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

Device: Use of plasma of neutral argon; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	30 days after the intervention
Global morbidity.	Evaluation of global morbidity using CTCAE v 4.0 scale.	Within the 30 days post-intervention
Global mortality.	Evaluation of global mortality using CTCAE v 4.0 scale.	Within the 30 days post-intervention

Collaborators and Investigators

• Sponsor: Maimónides Biomedical Research Institute of Córdoba
• Investigators: Principal Investigator: Alvaro Arjona-Sanchez, PhD, University Hospital Reina Sofía

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2021
• Primary Completion (ACTUAL): April 3, 2022
• Study Completion (ACTUAL): May 3, 2022

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (ACTUAL): May 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Cancer; Peritoneal carcinomatosis; Neutral argon plasma
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Peritoneal Diseases; Digestive System Neoplasms; Abdominal Neoplasms; Carcinoma; Peritoneal Neoplasms
• Other Study ID Numbers: FCO-PLASM-2020-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be shared after the conclusion of the study and the results were published
• IPD Sharing Time Frame: After the publication of the results
• IPD Sharing Access Criteria: upon request to the principal investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No