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临床试验/NCT04014426
NCT04014426已完成不适用

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

Institut du Cancer de Montpellier - Val d'Aurelle2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2018年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
试验地点
2
主要终点
Urinary levels of oxaliplatin - Non-exposed group

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Urinary levels of oxaliplatin - Non-exposed group

时间窗: At baseline

Urinary levels of oxaliplatin in heathy subject non-exposed to chemotherapy

Blood levels of oxaliplatin - Exposed group

时间窗: 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

时间窗: At baseline

Blood levels of oxaliplatin in heathy subject non-exposed to chemotherapy

Urinary levels of oxaliplatin - Exposed group

时间窗: Change from before PIPAC, 2hours after PIPAC and the next day after PIPAC

Urinary levels of oxaliplatin in healthcare workers in two PIPAC

次要结局

  • Oxaliplatin contamination of the operating room(Before PIPAC and 10min after PIPAC)

研究者

发起方
Institut du Cancer de Montpellier - Val d'Aurelle
申办方类型
Other
责任方
Sponsor

研究点 (2)

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