Evaluation of Healthcare Workers Safety During Pressurized Intraperitoneal Aerosol Chemotherapy

Not Applicable

Completed

• Conditions: Healthy Volunteers; Safety
• Interventions: Other: Blood sample; Other: Urinary sample

• Registration Number: NCT04014426
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

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 Timeline

• Study Start: 2018-01-02
• Primary Completion: 2018-07-04
• Study Completion: 2018-07-04
• Status Verified: 2019-06
• Study First Submitted: 2019-07-01
• Study First Submitted QC: 2019-07-09
• Last Update Submitted: 2019-07-09
• Study First Posted: 2019-07-10
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-exposed	Urinary sample	Healthy volunteers unexposed to chemotherapy
Exposed	Blood sample	Healthcare workers participating at two PIPAC
Exposed	Urinary sample	Healthcare workers participating at two PIPAC
Non-exposed	Blood sample	Healthy volunteers unexposed to chemotherapy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Oxaliplatin contamination of the operating room	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

Trial Locations

Locations (1)

ICM - Val d'Aurelle; 🇫🇷 Montpellier, France