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Abstract
ObjectivesPressurized intraperitoneal aerosol chemotherapy (PIPAC) is a promising treatment for peritoneal cancer that entails, however, potential risks for the caregivers in the operating room (OR). This study aimed to reach a consensus within the PIPAC community on a comprehensive safety protocol.MethodsActive PIPAC centers were invited to participate in a two-round Delphi process on 43 predefined items: concise summaries of the existing evidence were presented together with questions formulated using the population, intervention, comparator, and outcome framework. According to the Grading of Recommendations Assessment, Development, and Evaluation, the strength of recommendation was voted by panelists, accepting a consensus threshold of ≥50% of the agreement for any of the four grading options, or ≥70% in either direction.ResultsForty-seven out of 66 invited panelists answered both rounds (response rate 76%). The consensus was reached for 41 out of 43 items (95.3%). Strong and weak recommendations were issued for 30 and 10 items, respectively. A positive consensual recommendation was issued to activate laminar airflow without specific strength, neither strong nor weak. No consensus was reached for systematic glove change for caregivers with a high risk of exposure and filtering facepiece mask class 3 for caregivers with low risk of exposure.ConclusionsA high degree of consensus was reached for a comprehensive safety protocol for PIPAC, adapted to the risk of exposure for the different caregivers in the OR. This consensus can serve as a basis for education and help reach a high degree of adherence in daily practice.
Highlights
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) has been developed as a new drug delivery system to treat patients with nonresectable peritoneal metastases of various primaries [1,2,3].Chemotherapeutic agents (CA) are manipulated during PIPAC
The safety protocol was successfully validated under clinical conditions during the first PIPAC procedures with no platin traces detected in the air
No consensus was reached for two items (4.7%) after the two Delphi rounds, namely the change of gloves after 30 min for caregivers with a high risk of exposure and the use of filtering facepiece (FFP) mask class 3 for caregivers with a low risk of exposure
Summary
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) has been developed as a new drug delivery system to treat patients with nonresectable peritoneal metastases of various primaries [1,2,3].Chemotherapeutic agents (CA) are manipulated during PIPAC. Before the first-inhuman use, and in collaboration with an independent organization certified for occupational health risk assessment (DEKRA Industrials GmbH, Stuttgart, Germany), the pioneer team in Bielefeld performed a detailed risk assessment and developed a dedicated safety protocol. Girardot-Miglierina et al.: PIPAC safety consensus protocol included tightness of the abdomen, laminar airflow ventilation in the OR, controlled aerosol waste, remote control of the procedure, and wearing protective clothing, gloves, and glasses. The safety protocol was successfully validated under clinical conditions during the first PIPAC procedures with no platin traces detected in the air (detection limit: 0.000009 mg/m3). Assuming a platin exposition of 8 h daily, a maximal substance index
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