Pressurized intraperitoneal aerosol chemotherapy (PIPAC): occupational health and safety aspects

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Fig. 1

PIPAC simulation with smoke and artificial leakage. Sealing access trocars (a) were introduced into a sealed plastic box (b) with the same volume dimensions as the human abdominal cavity. The box was pressurized with CO₂ and steam. Via an artificial leakage (open access trocar), the steam (white bold arrows) was observed to be directed to the floor and not randomly distributed within the OR. This is caused by the laminar air flowing downward from the ceiling to the floor

Fig. 2

First PIPAC under real conditions. Access trocars (a) with the nebulizer (b) in situ. The chemotherapeutic agents were transported from the injector to the nebulizer via a high-pressure infusion line (c). CO₂ was injected into the abdominal cavity via a standard gas line (d) and the trocar (e) (camera trocar). At the end of the procedure, the chemotherapeutic capnoperitoneum was desufflated via line (f) over an aerosol filter into the air-waste system of the hospital. Dark arrows indicate the flow direction of the gas and chemotherapeutics. Asterisk Trocar sealing rings

FIG. 3

OR setup for first PIPAC and safety measurement. The OR is equipped with laminar airflow. The abdomen is tight. The procedure is remote controlled. Environmental air sampling was undertaken at the surgeon’s (a) and anesthesiologist’s (b) working positions. The pressure injector (c), sealing trocars, and nebulizer in situ (d) as well as the desufflation line (e) are shown. To minimize any possible chemotherapeutic exposure of the anesthesiology crew, a vertical transparent curtain dividing the laminar airflow was hung between the patient’s head and the site of chemotherapy application