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.
調査の概要
詳細な説明
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).
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Montpellier、フランス、34298
- ICM - Val d'Aurelle
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の: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) |
|
他の: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) |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Blood levels of oxaliplatin - Exposed group
時間枠: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
時間枠:At baseline
|
Blood levels of oxaliplatin in heathy subject non-exposed to chemotherapy
|
At baseline
|
|
Urinary levels of oxaliplatin - Exposed group
時間枠: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
時間枠:At baseline
|
Urinary levels of oxaliplatin in heathy subject non-exposed to chemotherapy
|
At baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Oxaliplatin contamination of the operating room
時間枠: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
|
協力者と研究者
捜査官
- スタディチェア:Olivia SGARBURA, MD、ICM - Institut régional du Cancer Montpellier
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- ICM-URC 2017/36
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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