학술논문
Establishment of a desirable dose using neutral argon plasma to eradicate miliary peritoneal implants: A phase I/II controlled trial.
Document Type
Academic Journal
Author
Pontes-García A; Unit of Surgical Oncology, Reina Sofía University Hospital, Córdoba, Spain.; Martínez-López A; GE09 Research in Peritoneal and Retroperitoneal Oncologic Surgery Group, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofía University Hospital, Department of Biochemistry and Molecular Biology, University of Cordoba, Córdoba, Spain; Unit of Pathology, Reina Sofia University Hospital, Córdoba, Spain.; Rodríguez-Ortiz L; Unit of Surgical Oncology, Reina Sofía University Hospital, Córdoba, Spain; GE09 Research in Peritoneal and Retroperitoneal Oncologic Surgery Group, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofía University Hospital, Department of Biochemistry and Molecular Biology, University of Cordoba, Córdoba, Spain.; Valenzuela-Molina F; Unit of Surgical Oncology, Reina Sofía University Hospital, Córdoba, Spain; GE09 Research in Peritoneal and Retroperitoneal Oncologic Surgery Group, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofía University Hospital, Department of Biochemistry and Molecular Biology, University of Cordoba, Córdoba, Spain.; Rufián-Andújar B; Unit of Surgical Oncology, Reina Sofía University Hospital, Córdoba, Spain; GE09 Research in Peritoneal and Retroperitoneal Oncologic Surgery Group, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofía University Hospital, Department of Biochemistry and Molecular Biology, University of Cordoba, Córdoba, Spain.; Sánchez-Hidalgo JM; Unit of Surgical Oncology, Reina Sofía University Hospital, Córdoba, Spain; GE09 Research in Peritoneal and Retroperitoneal Oncologic Surgery Group, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofía University Hospital, Department of Biochemistry and Molecular Biology, University of Cordoba, Córdoba, Spain.; Casado-Adam A; Unit of Surgical Oncology, Reina Sofía University Hospital, Córdoba, Spain; GE09 Research in Peritoneal and Retroperitoneal Oncologic Surgery Group, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofía University Hospital, Department of Biochemistry and Molecular Biology, University of Cordoba, Córdoba, Spain.; Gordon-Suarez A; Unit of Surgical Oncology, Reina Sofía University Hospital, Córdoba, Spain; GE09 Research in Peritoneal and Retroperitoneal Oncologic Surgery Group, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofía University Hospital, Department of Biochemistry and Molecular Biology, University of Cordoba, Córdoba, Spain.; Rufián-Peña S; Unit of Surgical Oncology, Reina Sofía University Hospital, Córdoba, Spain; GE09 Research in Peritoneal and Retroperitoneal Oncologic Surgery Group, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofía University Hospital, Department of Biochemistry and Molecular Biology, University of Cordoba, Córdoba, Spain.; Vázquez-Borrego MC; GE09 Research in Peritoneal and Retroperitoneal Oncologic Surgery Group, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofía University Hospital, Department of Biochemistry and Molecular Biology, University of Cordoba, Córdoba, Spain.; Romero-Ruiz A; GE09 Research in Peritoneal and Retroperitoneal Oncologic Surgery Group, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofía University Hospital, Department of Biochemistry and Molecular Biology, University of Cordoba, Córdoba, Spain.; Arjona-Sánchez A; Unit of Surgical Oncology, Reina Sofía University Hospital, Córdoba, Spain; GE09 Research in Peritoneal and Retroperitoneal Oncologic Surgery Group, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofía University Hospital, Department of Biochemistry and Molecular Biology, University of Cordoba, Córdoba, Spain. Electronic address: alvaroarjona@hotmail.com.
Source
Publisher: Elsevier Country of Publication: England NLM ID: 8504356 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1532-2157 (Electronic) Linking ISSN: 07487983 NLM ISO Abbreviation: Eur J Surg Oncol Subsets: MEDLINE
Subject
Language
English
Abstract
Introduction: Neutral argon plasma (NAP) system could meet the requirements to achieve oncological cytoreduction of peritoneal carcinomatosis with miliary lesions, minimizing the associated morbidity. This phase I/II trial aims to establish the desirable dose that is safe and effective in eliminating tumor cells with lower penetration.
Methods: Patients diagnosed with different origins for peritoneal carcinomatosis and miliary implants were selected for the study. The safe and potentially effective dose (desirability) of NAP was evaluated according to three factors: distance (mm), application time (s) and power (%), to evaluate the response variables such as the presence of tumor cells (Y/N) and the depth of penetration.
Results: Ten patients and 120 samples were evaluated and treated with NAP. There was no vascular or organ injury intraoperative using a pre-established dose of 100% (coagulation mode) at a distance of 2-3 cm. The distance was found to be correlated with the presence of the tumor cells in ex-vivo analysis, with an OR of 15.4 (4.0-111.4). The time and energy used were protective factors to eliminate tumor cells with an OR of 0.4 (0.1-0.9) and 0.8 (0.8-0.9), respectively. The safest and most effective desirability results were as follows i) energy 80% during 2-4 s with a distance of 2 cm (0.89), and ii) energy 100% during 2-4 s with a distance of 3 cm (0.90).
Conclusions: The use of NAP during a CRS and HIPEC is safe and effective for eradicating tumor cells on the peritoneal surface at suggested doses of energy, distance and duration.
Trial Identification: ClinicalTrials.gov Identifier: NCT04904042.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2023 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.)
Methods: Patients diagnosed with different origins for peritoneal carcinomatosis and miliary implants were selected for the study. The safe and potentially effective dose (desirability) of NAP was evaluated according to three factors: distance (mm), application time (s) and power (%), to evaluate the response variables such as the presence of tumor cells (Y/N) and the depth of penetration.
Results: Ten patients and 120 samples were evaluated and treated with NAP. There was no vascular or organ injury intraoperative using a pre-established dose of 100% (coagulation mode) at a distance of 2-3 cm. The distance was found to be correlated with the presence of the tumor cells in ex-vivo analysis, with an OR of 15.4 (4.0-111.4). The time and energy used were protective factors to eliminate tumor cells with an OR of 0.4 (0.1-0.9) and 0.8 (0.8-0.9), respectively. The safest and most effective desirability results were as follows i) energy 80% during 2-4 s with a distance of 2 cm (0.89), and ii) energy 100% during 2-4 s with a distance of 3 cm (0.90).
Conclusions: The use of NAP during a CRS and HIPEC is safe and effective for eradicating tumor cells on the peritoneal surface at suggested doses of energy, distance and duration.
Trial Identification: ClinicalTrials.gov Identifier: NCT04904042.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2023 Elsevier Ltd, BASO ~ The Association for Cancer Surgery, and the European Society of Surgical Oncology. All rights reserved.)