Consensus statement on safety measures for pressurized intraperitoneal aerosol chemotherapy

Abstract

Objectives Pressurized 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. Methods Active 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. Results Forty-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. Conclusions A 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.

Selection Criteria for Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Treatment in Patients with Peritoneal Metastases

“…The PIPAC procedure has been described previously and was applied according to current recommendations and safety protocols [9,20]. Oxaliplatin was applied at a dose of 92 mg/m 2 for carcinomatosis of mostly colorectal origin and, selectively, for other digestive origins (gastric or pancreatic cancer).…”

The role of cytology in patients undergoing pressurized intraperitoneal aerosol chemotherapy (PIPAC) treatment for peritoneal carcinomatosis

“…All procedures were performed in a standardized manner according to the PIPAC certification course and in line with recent international expert consensus [ 9 , 10 ]. In the absence of ascites, approximately 100 cc of saline were instilled in the right and left hypochondriums, in addition to 100 cc in the pelvis.…”

Assessment of Treatment Response after Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC) for Appendiceal Peritoneal Metastases

“…Surgical technique, safety and treatment protocols underlie little variation between centers according to recent investigations [ 18 , 19 ] due to a standardized training curriculum [ 20 ]. Main features of PIPAC treatment including technical aspects have been summarized recently [ 21 ] and include a two-trocar technique (balloon trocars), a standardized safety procotol (advanced ventilation system, zero flow, remote application), and constant pressure conditions of 12 mmHg [ 22 , 23 ]. The diagnostic phase includes documentation of disease extent (Peritoneal cancer index: PCI), aspiration of ascites (volume, cytology) and 3–4 biopsies from different areas of the abdomen for grading of histological response (outlines below).…”