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

NCT04904042 | Completed

• 1 other identifier: FCO-PLASM-2020-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritoneal Carcinomatosis

Keywords

Peritoneal carcinomatosis; Cancer; Neutral argon plasma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  During the surgery and through study completion, an average of 1 year.

• Morbidity associated with treatment.

  30 days after the intervention

• Mortality associated with treatment.

  30 days after the intervention

• Global morbidity.

  Within the 30 days post-intervention

• Global mortality.

  Within the 30 days post-intervention

Study Arms (1)

Use of plasma of neutral argon

EXPERIMENTAL

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

Interventions

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.

Use of plasma of neutral argon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead

Study Sites (1)

University Hospital Reina Sofia

Córdoba, 14004, Spain

Location

Related Publications (1)

• Pontes-Garcia A, Martinez-Lopez A, Rodriguez-Ortiz L, Valenzuela-Molina F, Rufian-Andujar B, Sanchez-Hidalgo JM, Casado-Adam A, Gordon-Suarez A, Rufian-Pena S, Vazquez-Borrego MC, Romero-Ruiz A, Arjona-Sanchez A. Establishment of a desirable dose using neutral argon plasma to eradicate miliary peritoneal implants: A phase I/II controlled trial. Eur J Surg Oncol. 2023 Sep;49(9):106978. doi: 10.1016/j.ejso.2023.07.004. Epub 2023 Jul 11.

  PMID: 37460370 DERIVED

MeSH Terms

Conditions

Peritoneal Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Alvaro Arjona-Sanchez, PhD

  University Hospital Reina Sofia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 27, 2021
• Study Start: June 1, 2021
• Primary Completion: April 3, 2022
• Study Completion: May 3, 2022
• Last Updated: June 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: After the publication of the results
• Access Criteria: upon request to the principal investigator

Locations

ES (1)