Evaluation of Healthcare Workers Safety During Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC-Secure)
Evaluation of Oxaliplatin Exposure and Security of Healthcare Workers During Pressurized Intraperitoneal Aerosol Chemotherapy
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.
研究概览
详细说明
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).
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Montpellier、法国、34298
- ICM - Val d'Aurelle
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他:Exposed
Healthcare workers participating at two PIPAC
|
Exposed group:
Non-exposed group: - During the morning (8 to 10 a.m): 1 EDTA tube of 6 ml (T0) Exposed group:
Non-exposed group: - During the morning (8 to 10 a.m) (T0) |
|
其他:Non-exposed
Healthy volunteers unexposed to chemotherapy
|
Exposed group:
Non-exposed group: - During the morning (8 to 10 a.m): 1 EDTA tube of 6 ml (T0) Exposed group:
Non-exposed group: - During the morning (8 to 10 a.m) (T0) |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Blood levels of oxaliplatin - Exposed group
大体时间:Change from before PIPAC and 2hours after PIPAC
|
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
大体时间:At baseline
|
Blood levels of oxaliplatin in heathy subject non-exposed to chemotherapy
|
At baseline
|
|
Urinary levels of oxaliplatin - Exposed group
大体时间:Change from before PIPAC, 2hours after PIPAC and the next day after PIPAC
|
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
大体时间:At baseline
|
Urinary levels of oxaliplatin in heathy subject non-exposed to chemotherapy
|
At baseline
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Oxaliplatin contamination of the operating room
大体时间:Before PIPAC and 10min after PIPAC
|
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
|
合作者和调查者
调查人员
- 学习椅:Olivia SGARBURA, MD、ICM - Institut régional du Cancer Montpellier
出版物和有用的链接
一般刊物
- 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.
- 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.
- 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.
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- ICM-URC 2017/36
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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