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出境医 / 临床实验 / Evaluation of Healthcare Workers Safety During Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC-Secure)

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

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Safety Healthy Volunteers Other: Blood sample Other: Urinary sample Not Applicable

Detailed Description:

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).

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Exposed/ Non-exposed
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Oxaliplatin Exposure and Security of Healthcare Workers During Pressurized Intraperitoneal Aerosol Chemotherapy
Actual Study Start Date : January 2, 2018
Actual Primary Completion Date : July 4, 2018
Actual Study Completion Date : July 4, 2018
Arms and Interventions
Arm Intervention/treatment
Exposed
Healthcare workers participating at two PIPAC
 Other: Blood sample

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)


Other: Urinary sample

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)
Non-exposed
Healthy volunteers unexposed to chemotherapy
 Other: Blood sample

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)


Other: Urinary sample

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)
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Locations
Layout table for location information
France
ICM - Val d'Aurelle
Montpellier, France, 34298
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
Layout table for investigator information
Study Chair: Olivia SGARBURA, MD ICM - Institut régional du Cancer Montpellier
Tracking Information
First Submitted Date  ICMJE July 1, 2019
First Posted Date  ICMJE July 10, 2019
Last Update Posted Date July 10, 2019
Actual Study Start Date  ICMJE January 2, 2018
Actual Primary Completion Date July 4, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • 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
  • Blood levels of oxaliplatin - Non-exposed group [ Time Frame: At baseline ]
    Blood levels of oxaliplatin in heathy subject non-exposed to chemotherapy
  • 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
  • Urinary levels of oxaliplatin - Non-exposed group [ Time Frame: At baseline ]
    Urinary levels of oxaliplatin in heathy subject non-exposed to chemotherapy
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2019) 		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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Healthcare Workers Safety During Pressurized Intraperitoneal Aerosol Chemotherapy
Official Title  ICMJE Evaluation of Oxaliplatin Exposure and Security of Healthcare Workers During Pressurized Intraperitoneal Aerosol Chemotherapy
Brief Summary

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.
Detailed Description

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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Exposed/ Non-exposed
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Safety
  • Healthy Volunteers
Intervention  ICMJE
  • Other: Blood sample

    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)

  • Other: Urinary sample

    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)
Study Arms  ICMJE
  • Exposed
    Healthcare workers participating at two PIPAC
    Interventions:
    • Other: Blood sample
    • Other: Urinary sample
  • Non-exposed
    Healthy volunteers unexposed to chemotherapy
    Interventions:
    • Other: Blood sample
    • Other: Urinary sample
Publications *
  • Tempfer CB, Celik I, Solass W, Buerkle B, Pabst UG, Zieren J, Strumberg D, Reymond MA. Activity of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with cisplatin and doxorubicin in women with recurrent, platinum-resistant ovarian cancer: preliminary clinical experience. Gynecol Oncol. 2014 Feb;132(2):307-11. doi: 10.1016/j.ygyno.2013.11.022. Epub 2013 Nov 23.
  • Markman M. Intraperitoneal antineoplastic drug delivery: rationale and results. Lancet Oncol. 2003 May;4(5):277-83. Review.
  • Solass W, Giger-Pabst U, Zieren J, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy (PIPAC): occupational health and safety aspects. Ann Surg Oncol. 2013 Oct;20(11):3504-11. doi: 10.1245/s10434-013-3039-x. Epub 2013 Jun 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2019) 		18
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 4, 2018
Actual Primary Completion Date July 4, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04014426
Other Study ID Numbers  ICMJE ICM-URC 2017/36
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institut du Cancer de Montpellier - Val d'Aurelle
Study Sponsor  ICMJE Institut du Cancer de Montpellier - Val d'Aurelle
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Olivia SGARBURA, MD ICM - Institut régional du Cancer Montpellier
PRS Account Institut du Cancer de Montpellier - Val d'Aurelle
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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