Evaluation of Healthcare Workers Safety During Pressurized Intraperitoneal Aerosol Chemotherapy

Healthy Volunteers Clinical Trial

— PIPAC-Secure  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04014426
• Other study ID #: ICM-URC 2017/36
• Status: Completed
• Phase: N/A
• Start date: January 2, 2018
• Est. completion date: July 4, 2018

Study information

• Verified date: June 2019
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 4, 2018
• Est. primary completion date: July 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers
• Safety

Intervention

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)
• 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)

Locations

Country	Name	City	State
France	ICM - Val d'Aurelle	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

References & Publications (3)

Markman M. Intraperitoneal antineoplastic drug delivery: rationale and results. Lancet Oncol. 2003 May;4(5):277-83. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood levels of oxaliplatin - Exposed group	Blood levels of oxaliplatin in healthcare workers in two PIPAC	Change from before PIPAC and 2hours after PIPAC
Primary	Blood levels of oxaliplatin - Non-exposed group	Blood levels of oxaliplatin in heathy subject non-exposed to chemotherapy	At baseline
Primary	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
Primary	Urinary levels of oxaliplatin - Non-exposed group	Urinary levels of oxaliplatin in heathy subject non-exposed to chemotherapy	At baseline
Secondary	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