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Completed

NCT Number: NCT04014426

Evaluation of Healthcare Workers Safety 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICM - Val d'Aurelle

Montpellier, 34298, France

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

blood sample

Other

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)

urinary sample

Other

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)

Primary outcomes

  1. Blood levels of oxaliplatin - Exposed group

    Time frame: Change from before PIPAC and 2hours after PIPAC

    Blood levels of oxaliplatin in healthcare workers in two PIPAC

  2. Blood levels of oxaliplatin - Non-exposed group

    Time frame: At baseline

    Blood levels of oxaliplatin in heathy subject non-exposed to chemotherapy

  3. Urinary levels of oxaliplatin - Exposed group

    Time frame: Change from before PIPAC, 2hours after PIPAC and the next day after PIPAC

    Urinary levels of oxaliplatin in healthcare workers in two PIPAC

  4. Urinary levels of oxaliplatin - Non-exposed group

    Time frame: At baseline

    Urinary levels of oxaliplatin in heathy subject non-exposed to chemotherapy

Secondary outcomes

  1. Oxaliplatin contamination of the operating room

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Official study title

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

Acronym: PIPAC-Secure

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 10, 2019
Registry last updated
Jul 10, 2019

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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