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Evaluation of Healthcare Workers Safety During Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC-Secure)

Evaluation of Oxaliplatin Exposure and Security of Healthcare Workers During Pressurized Intraperitoneal Aerosol Chemotherapy

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a new treatment that applies chemotherapeutic drugs into the peritoneal cavity as an aerosol. It is used to treat patient with Peritoneal Carcinomatosis (PC). During this procedure, healthcare workers may be under risks of exposure to cytotoxic treatments.

The purpose of this study is to evaluate the safety of the heathcare workers and the risk of operation room Oxaliplatin's contamination during a PIPAC.

Studieoversikt

Status

Fullført

Detaljert beskrivelse

Peritoneal carcinomatosis (PC), which was long considered as a terminal stage, is now potentially curable. Nevertheless, in most cases, the surgical treatment of PC is limited by the disease extent which is commonly measured with the Peritoneal Carcinomatosis Index (PCI). For the patients that are not considered good candidates for resection, there are very few alternatives. Systemic chemotherapy may have limited or no effect therefore an alternative solution is needed for these patients.

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a new treatment that applies chemotherapeutic drugs into the peritoneal cavity as an aerosol under pressure through minimal laparoscopic surgery.

Nevertheless, as it is the case for most technologies, security is not always completely tested. The innovative team started by establishing a set of security rules that concern the operating room ventilation, distance monitoring of the patient during nebulization, evacuation of the aerosols in a closed system. In a work dedicated to occupational hazards, the authors followed the following steps: identification of hazardous substances and dose; identification of possible exposure ways; simulation of the PIPAC procedure with nontoxic aerosols and smoke; redaction of standard operating procedures (SOP); second simulation according to the SOP; informing and training the health care workers; and performance of the first two PIPAC procedures with chemotherapeutic substances and workplace measurements under real conditions. At the end of the study, there were no traces of doxorubicin or cisplatin (the two drugs used in the two consecutive test procedures) in the operating room air, neither to the position of the anesthesiologist, nor of the surgeon.

This study does not concern PIPAC with oxaliplatin, nor does it research the presence of the drugs in the health caregivers.

Therefore we considered mandatory to further investigate occupational hazards in the specific case of oxaliplatin by focusing more on the healthcare workers and partially applying the same protocols as in the case of Heated intraperitoneal chemotherapy (HIPEC).

Studietype

Intervensjonell

Registrering (Faktiske)

18

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Montpellier, Frankrike, 34298
        • ICM - Val d'Aurelle

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

Male or female subjects ≥ 18 and ≤ 70 years old

  • Exposed subjects: The healthcarers involved in two different PIPAC using oxaliplatin (Surgeon, Anesthesiste, Block nurse …)
  • Non-exposed subjects: Healthy volunteers not exposed to oxaliplatin or other platin based chemotherapy (administrative function).
  • Must be affiliated to a social security system
  • Informed consent agreement and signature

Exclusion Criteria:

  • Legal incapacity or physical, psychological or mental status interfering with the subject's ability to sign the inform consent or to terminate the study

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Exposed
Healthcare workers participating at two PIPAC

Exposed group:

  • 15 to 30 minutes before the start of the procedure: 1 EDTA tube of 6 ml for blood (T0)
  • 2hours after the end of the procedure: 1 EDTA tube of 6 ml (T1)

Non-exposed group:

- During the morning (8 to 10 a.m): 1 EDTA tube of 6 ml (T0)

Exposed group:

  • 15 to 30 min before the PIPAC procedure (T0)
  • 2hours after the end of the procedure (T1)
  • The next morning after the procedure (T2)

Non-exposed group:

- During the morning (8 to 10 a.m) (T0)

Annen: Non-exposed
Healthy volunteers unexposed to chemotherapy

Exposed group:

  • 15 to 30 minutes before the start of the procedure: 1 EDTA tube of 6 ml for blood (T0)
  • 2hours after the end of the procedure: 1 EDTA tube of 6 ml (T1)

Non-exposed group:

- During the morning (8 to 10 a.m): 1 EDTA tube of 6 ml (T0)

Exposed group:

  • 15 to 30 min before the PIPAC procedure (T0)
  • 2hours after the end of the procedure (T1)
  • The next morning after the procedure (T2)

Non-exposed group:

- During the morning (8 to 10 a.m) (T0)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Blood levels of oxaliplatin - Exposed group
Tidsramme: Change from before PIPAC and 2hours after PIPAC
Blood levels of oxaliplatin in healthcare workers in two PIPAC
Change from before PIPAC and 2hours after PIPAC
Blood levels of oxaliplatin - Non-exposed group
Tidsramme: At baseline
Blood levels of oxaliplatin in heathy subject non-exposed to chemotherapy
At baseline
Urinary levels of oxaliplatin - Exposed group
Tidsramme: Change from before PIPAC, 2hours after PIPAC and the next day after PIPAC
Urinary levels of oxaliplatin in healthcare workers in two PIPAC
Change from before PIPAC, 2hours after PIPAC and the next day after PIPAC
Urinary levels of oxaliplatin - Non-exposed group
Tidsramme: At baseline
Urinary levels of oxaliplatin in heathy subject non-exposed to chemotherapy
At baseline

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Oxaliplatin contamination of the operating room
Tidsramme: Before PIPAC and 10min after PIPAC
Oxaliplatin dosed on standardized gazes used to clear four different spots in the operating room: the ceiling lamp, the electroagulation device, the laparoscopy tower and the anesthesia monitoring screen
Before PIPAC and 10min after PIPAC

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studiestol: Olivia SGARBURA, MD, ICM - Institut régional du Cancer Montpellier

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

2. januar 2018

Primær fullføring (Faktiske)

4. juli 2018

Studiet fullført (Faktiske)

4. juli 2018

Datoer for studieregistrering

Først innsendt

1. juli 2019

Først innsendt som oppfylte QC-kriteriene

9. juli 2019

Først lagt ut (Faktiske)

10. juli 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juli 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. juli 2019

Sist bekreftet

1. juni 2019

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere