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.

Figure 1

Flow diagram of the literature search and selection of articles for review Search of the EU Clinical Trials Register (EudraCT) and the US National Library of Medicine Trials Register (http://clinicaltrials.gov) is also included. PIPAC, pressurized intraperitoneal aerosol chemotherapy.

Figure 2

Adoption of pressurized intraperitoneal aerosol chemotherapy according to the IDEAL criteria Studies were identified using the search strategy described in Fig. 1. Included studies were then reviewed by a single author and assigned a stage of innovation according to the description of the stage and proposed method of investigation suggested by the IDEAL paradigm, as described in Table  1. Study centres are described by the city where the institution of the lead author was located. The number of studies published by each centre is shown, broken down by year and stage of innovation: I, Idea; D, Development; E, Exploration; A, Assessment; P, protocol paper. *Protocol from http://clinicaltrials.gov. †Protocol for multicentre study; other authors are from centres in Lausanne (Switzerland), Odense (Denmark), Paris (France), Tübingen (Germany) and Turin (Italy). ‡Multicentre study; other authors are from centres in Clermont Ferrand and Montpellier (France). §Protocol for multicentre study; other authors are from centres in Berlin, Bochum, Tübingen and Wiesbaden (Germany) and Rome (Italy). ¶Protocol for multicentre study; other authors are from centres in Lyon and Paris (France). #Protocol for multicentre study; other authors are from centres in Berlin, Bochum, Leipzig, Regensburg and Tübingen (Germany) and Geneva (Switzerland).