Department of Pathology, Ruhr University Bochum, Bochum, Germany.
Ann Surg Oncol. 2013 Oct;20(11):3504-11. doi: 10.1245/s10434-013-3039-x. Epub 2013 Jun 14.
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel approach for treating peritoneal carcinomatosis. First encouraging results have been obtained in human patients. However, delivering chemotherapy as an aerosol might result in an increased risk of exposure to health care workers, as compared with other administration routes.
PIPAC was applied in two human patients using chemotherapeutic drugs (doxorubicin and cisplatin), and air contamination levels were measured under real clinical conditions. Air was collected on a cellulose nitrate filter with a flow of 22.5 m(3)/h. To exclude any risk for health care workers, both procedures were remote controlled. Toxicological research of cisplatin was performed according to NIOSH 7300 protocol. Sampling and analysis were performed by an independent certification organization.
The following safety measures were implemented: closed abdomen, laminar airflow, controlled aerosol waste, and protection curtain. No cisplatin was detected in the air (detection limit < 0.000009 mg/m(3)) at the working positions of the surgeon and the anesthesiologist under real PIPAC conditions.
For the drugs tested, PIPAC is in compliance with European Community working safety law and regulations. Workplace contamination remains below the tolerance margin. The safety measures and conditions as defined above are sufficient. Further protecting devices, such as particulate (air purifying) masks, are not necessary. PIPAC can be used safely in the clinical setting if the conditions specified above are met. However, a toxicological workplace analysis must be performed to confirm that the procedure as implemented complies with local regulations.
加压腹腔内气溶胶化疗（PIPAC）是一种治疗腹膜癌病的新方法。在人体患者中已获得了初步令人鼓舞的结果。然而，与其他给药途径相比，将化疗作为气溶胶给药可能会增加医护人员接触的风险。
在两名人类患者中应用 PIPAC，并在真实临床条件下测量空气污染物水平。使用流量为 22.5 m³/h 的硝酸纤维素滤器收集空气。为了排除对医护人员的任何风险，两个程序均采用遥控操作。根据 NIOSH 7300 协议对顺铂进行毒理学研究。采样和分析由独立认证机构进行。
实施了以下安全措施：封闭腹部、层流空气、控制气溶胶废物和保护幕。在真实的 PIPAC 条件下，手术医生和麻醉师的工作位置未检测到空气中的顺铂（检测限<0.000009 mg/m³）。
对于测试的药物，PIPAC 符合欧洲共同体工作安全法和法规。工作场所污染仍低于容忍限度。上述定义的安全措施和条件是足够的。不需要进一步的保护设备，如颗粒（空气净化）口罩。如果满足上述规定，则可以在临床环境中安全使用 PIPAC。但是，必须进行毒理学工作场所分析以确认所实施的程序符合当地法规。
