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Completed

NCT Number: NCT04904042

Study of Safety and Efficiency of 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.

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Key information

Conditions

Peritoneal Carcinomatosis Abdominal Neoplasms Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site Peritoneal Diseases Peritoneal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Reina Sofia

Córdoba, 14004, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Use of plasma of neutral argon

Device

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.

Primary outcomes

  1. Pathological evaluation

    Time frame: 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 outcomes

  1. Evaluation of mesentery vascular damage and damage to the intestinal serosa.

    Time frame: 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.

  2. Morbidity associated with treatment.

    Time frame: 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.

  3. Mortality associated with treatment.

    Time frame: 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.

  4. Global morbidity.

    Time frame: Within the 30 days post-intervention

    Evaluation of global morbidity using CTCAE v 4.0 scale.

  5. Global mortality.

    Time frame: Within the 30 days post-intervention

    Evaluation of global mortality using CTCAE v 4.0 scale.

Sponsors and collaborators

Lead sponsor

Maimónides Biomedical Research Institute of Córdoba

Other

Registry information

Official study title

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.

Acronym: Plasmajet

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 27, 2021
Registry last updated
Jun 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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