Pressurized intraperitoneal aerosol chemotherapy: a review of the introduction of a new surgical technology using the IDEAL framework

Abstract

Background The IDEAL (Idea, Development, Evaluation, Assessment, Long‐term study) framework is a scheme of investigation for innovative surgical therapeutic interventions. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a procedure based on laparoscopy to deliver intraperitoneal chemotherapy for peritoneal metastases, introduced in 2011. The aim of this article was to review literature on PIPAC and assess whether development of the technique has followed the IDEAL framework. Methods A search of MEDLINE and Embase was carried out to identify scientific reports on PIPAC published between January 2000 and February 2019. The studies were categorized according to the IDEAL stages. Results Eighty‐six original research papers on PIPAC were identified. There were 23 stage 0, 18 stage 1, 25 stage 2a and six stage 2b studies. Protocol papers for stage 1, 2b and 3 studies, and trial registrations for stage 2a studies, were also identified. The number of centres publishing reports and the number of publications has increased each year. Overall, there has been progression through the IDEAL stages; however, about 60 per cent of clinical reports published in 2018 were stage 1 Idea‐type studies. Conclusion Since its introduction, studies investigating PIPAC have progressed in line with the IDEAL framework. However, the majority of studies reported recently were stage 0 and 1 studies.

Pressurized intraperitoneal aerosol chemotherapy with oxaliplatin (PIPAC-OX) in patients with colorectal peritoneal metastases—a systematic review

“…Five other studies have performed a systematic review of clinical studies on PIPAC for the treatment of peritoneal metastases (10,(41)(42)(43)(44). However, none of these systematic reviews specifically focused on PIPAC-OX in patients with CPM alone and reported on the interpretability of the results of included studies.…”

Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC)-directed treatment of peritoneal metastasis in end-stage colo-rectal cancer patients

“…Ongoing and future trials have to clarify the role of this therapeutic concept in these settings [27]. Current and future challenges for PIPAC has recently been surveyed [28,29]. The dose of oxaliplatin currently applied during PIPAC was determined arbitrarily and copied the drug concentration in the aerosol as practiced in the HIPEC perfusate [30].…”

Intraperitoneal Chemotherapy for Peritoneal Metastases: Technical Innovations, Preclinical and Clinical Advances and Future Perspectives

“…PIPAC has the advantage of a higher pressure that does not exceed tumor interstitial pressure. However, it seems important to underline that the majority of the studies investigating this procedure since its introduction in 2011 have not encompassed the IDEAL (Idea, Development, Evaluation, Assessment, Long-term study, Framework) framework [ 38 ]. The PIPAC procedure was meticulously tested in a porcine model and compared to washing techniques.…”