Evaluation of Healthcare Workers Safety During Pressurized Intraperitoneal Aerosol Chemotherapy

NCT ID: NCT04014426

Last Updated: 2019-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-02
• Study Completion Date: 2018-07-04

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).

Conditions

Safety; Healthy Volunteers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Exposed

Healthcare workers participating at two PIPAC

Group Type: OTHER

Blood sample

Intervention Type: 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

Intervention Type: 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)

Non-exposed

Healthy volunteers unexposed to chemotherapy

Group Type: OTHER

Blood sample

Intervention Type: 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

Intervention Type: 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)

Interventions

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)

Intervention Type: 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)

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivia SGARBURA, MD

Role: STUDY_CHAIR

ICM - Institut régional du Cancer Montpellier

Locations

ICM - Val d'Aurelle

Montpellier, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 24275155 (View on PubMed)

Markman M. Intraperitoneal antineoplastic drug delivery: rationale and results. Lancet Oncol. 2003 May;4(5):277-83. doi: 10.1016/s1470-2045(03)01074-x.

Reference Type: BACKGROUND

PMID: 12732164 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23765417 (View on PubMed)

Larroque M, Arnaudguilhem C, Bouyssiere B, Quenet F, Bouazza N, Jarlier M, Boulabas S, Mounicou S, Sgarbura O. Evaluation of the environmental contamination and exposure risk in medical/non-medical staff after oxaliplatin-based pressurized intraperitoneal aerosol chemotherapy. Toxicol Appl Pharmacol. 2021 Oct 15;429:115694. doi: 10.1016/j.taap.2021.115694. Epub 2021 Aug 21.

Reference Type: DERIVED

PMID: 34428445 (View on PubMed)

Other Identifiers

ICM-URC 2017/36

Identifier Type: -

Identifier Source: org_study_id