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Evaluation of Healthcare Workers Safety During Pressurized Intraperitoneal Aerosol Chemotherapy

NCT04014426 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-07-10

No results posted yet for this study

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

Interventions

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)

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)

Sponsors & Collaborators

  • Institut du Cancer de Montpellier - Val d'Aurelle

    lead OTHER

Principal Investigators

  • Olivia SGARBURA, MD · ICM - Institut régional du Cancer Montpellier

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-02
Primary Completion
2018-07-04
Completion
2018-07-04

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04014426 on ClinicalTrials.gov