Evaluation of Healthcare Workers Safety During Pressurized Intraperitoneal Aerosol Chemotherapy

NCT04014426 | Completed

• 1 other identifier: ICM-URC 2017/36
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Safety; Healthy Volunteers

Keywords

Peritoneal Carcinomatosis; Healthcare Workers; Security; Pressurized Intraperitoneal Aerosol Chemotherapy; Aerosols/administration & dosage; Oxaliplatin

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Oxaliplatin contamination of the operating room

  Before PIPAC and 10min after PIPAC

Study Arms (2)

Exposed

OTHER

Healthcare workers participating at two PIPAC

Other: Blood sample; Other: Urinary sample

Non-exposed

OTHER

Healthy volunteers unexposed to chemotherapy

Other: Blood sample; Other: Urinary sample

Interventions

Blood sample 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)

Exposed; Non-exposed

Urinary sample 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)

Exposed; Non-exposed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Legal incapacity or physical, psychological or mental status interfering with the subject's ability to sign the inform consent or to terminate the study

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

ICM - Val d'Aurelle

Montpellier, 34298, France

Location

Related Publications (4)

• 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.

  PMID: 24275155 BACKGROUND

• 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.

  PMID: 12732164 BACKGROUND

• 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.

  PMID: 23765417 BACKGROUND

• 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.

  PMID: 34428445 DERIVED

MeSH Terms

Conditions

Peritoneal Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Olivia SGARBURA, MD

  ICM - Institut régional du Cancer Montpellier

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Exposed/ Non-exposed

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 10, 2019
• Study Start: January 2, 2018
• Primary Completion: July 4, 2018
• Study Completion: July 4, 2018
• Last Updated: July 10, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)