Status:
COMPLETED
Study of Safety and Efficiency of the Use of Neutral Argon Plasma in Cyto-reduction of Miliary Implants in the Peritoneal Surface.
Lead Sponsor:
Maimónides Biomedical Research Institute of Córdoba
Conditions:
Peritoneal Carcinomatosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04904042
Start Date
June 1 2021
End Date
May 3 2022
Last Update
June 2 2022
Active Locations (1)
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1
University Hospital Reina Sofia
Córdoba, Spain, 14004