Evaluation of Healthcare Workers Safety During Pressurized Intraperitoneal Aerosol Chemotherapy

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Safety, Healthy Volunteers

Intervention / Treatment
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* Other: Blood sample
* Other: Urinary sample


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Exposed/ Non-exposed
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Exposed<br>Healthcare workers participating at two PIPAC | Other: Blood sample<br>* 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)<br>Other: Urinary sample<br>* 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)<br>|
| Other: Non-exposed<br>Healthy volunteers unexposed to chemotherapy | Other: Blood sample<br>* 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)<br>Other: Urinary sample<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood levels of oxaliplatin - Exposed group | 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 | Blood levels of oxaliplatin in heathy subject non-exposed to chemotherapy | At baseline | 
| Urinary levels of oxaliplatin - Exposed group | 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 | Urinary levels of oxaliplatin in heathy subject non-exposed to chemotherapy | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxaliplatin contamination of the operating room | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peritoneal Carcinomatosis, Healthcare Workers, Security, Pressurized Intraperitoneal Aerosol Chemotherapy, Aerosols/administration & dosage, Oxaliplatin