Pressurized intraperitoneal aerosol chemotherapy (PIPAC): updated systematic review using the IDEAL framework

Baggaley, Alice E; Lafaurie, Guillaume B R C; Tate, Sophia; Boshier, Piers R; Case, A.N.; Prosser, S.; Torkington, Jared; Jones, Sadie; Gwynne, S.; Peters, Christopher J.

doi:10.1093/bjs/znac284

Cited by 11 publications

(9 citation statements)

References 147 publications

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“…The evaluation for interventional therapies in the IDEAL-D framework includes four stages comprising the preclinical phase (stage 0), first-in-human studies (stage 1), prospective developmental/exploratory studies (stage 2), large randomized controlled trials/or equivalent studies (stage 3) and long-term surveillance studies and registries (stage 4) [ 18 , 19 ]. While the original nozzle technology has completed phase I—IIb (IDEAL-D stage 2) [ 20 ] and phase III trials (IDEAL-D stage 3) are ongoing [ 4 , 5 ], only limited phase I (IDEAL-D stage 1) clinical user data has been published for nozzle C (MCR-4 Topol ® ) [ 21 ]. Such data are lacking for nozzle B and D (IDEAL-D stage 0).…”

Section: Discussionmentioning

confidence: 99%

Performance of different nebulizers in clinical use for Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC)

Göhler,

Oelschlägel,

Ouaissi

et al. 2024

PLoS ONE

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Objective Technical ex-vivo comparison of commercial nebulizer nozzles used for Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC). Methods The performance of four different commercial nebulizer nozzles (Nebulizer; HurriChemTM; MCR-4 TOPOL®; QuattroJet) was analysed concerning: i) technical design and principle of operation, ii) operational pressure as function of the liquid flow rate, iii) droplet size distribution via laser diffraction spectrometry, iv) spray cone angle, spray cone form as well as horizontal drug deposition by image-metric analyses and v) chemical resistance via exposing to a cytostatic solution and chemical composition by means of spark optical emission spectral analysis. Results The Nebulizer shows quasi an identical technical design and thus also a similar performance (e.g., mass median droplet size of 29 μm) as the original PIPAC nozzles (MIP/ CapnoPen). All other nozzles show more or less a performance deviation to the original PIPAC nozzles. The HurriChemTM has a similar design and principle of operation as the Nebulizer, but provides a finer aerosol (22 μm). The principle of operation of MCR-4 TOPOL® and QuattroJet differ significantly from that of the original PIPAC nozzle technology. The MCR-4 TOPOL® offers a hollow spray cone with significantly larger droplets (50 μm) than the original PIPAC nozzles. The QuattroJet generates an aerosol (22 μm) similar to that of the HurriChemTM but with improved spatial drug distribution. Conclusion The availability of new PIPAC nozzles is encouraging but can also have a negative impact if their performance and efficacy is unknown. It is recommended that PIPAC nozzles that deviate from the current standard should be subject to bioequivalence testing and implementation in accordance with the IDEAL-D framework prior to routine clinical use.

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Section: Discussionmentioning

confidence: 99%

Performance of different nebulizers in clinical use for Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC)

Göhler,

Oelschlägel,

Ouaissi

et al. 2024

PLoS ONE

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show abstract

“…Therefore, before their broad clinical use, the individual innovation phases should be systematically tested, ideally following the recommendation of the IDEAL-D framework for the introduction of medical devices [15, 16]. While the original nozzle technology has completed phase I - IIb [17] and phase III trials are ongoing [4, 5], only limited phase I clinical user data has been published for nozzle C (MCR-4 Topol ® ) [18]. Such data are lacking for nozzle B and D.…”

Section: Discussionmentioning

confidence: 99%

Comparative Analysis of Nebulizers in Clinical use for Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC)

Goehler

Oelschlaegel²,

Ouaïssi

et al. 2023

Preprint

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Objective: Technical ex-vivo comparison of commercial nebulizer nozzles used for Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC). Methods: The performance of four different commercial nebulizer nozzles (Nebulizer; HurriChem; MCR-4 TOPOL; QuattroJet) was analysed concerning: i) technical design and principle of operation, ii) operational pressure as function of the liquid flow rate, iii) droplet size distribution via laser diffraction spectrometry, iv) spray cone angle, spray cone form as well as horizontal drug deposition by image-metric analyses and v) chemical resistance via exposing to a cytostatic solution and chemical composition by means of spark optical emission spectral analysis. Results: The Nebulizer shows quasi an identical technical design and thus also a similar performance (e.g., mass median droplet size of 29 micrometer) as the original PIPAC nozzles (MIP/ CapnoPen). All other nozzles show more or less a performance deviation to the original PIPAC nozzles. The HurriChem has a similar design and principle of operation as the Nebulizer, but provides a finer aerosol (22 micrometer). The principle of operation of MCR-4 TOPOL and QuattroJet differ significantly from that of the original PIPAC nozzle technology. The MCR-4 TOPOL offers a hollow spray cone with significantly larger droplets (50 micrometer) than the original PIPAC nozzles. The QuattroJet generates an aerosol (22 micrometer) similar to that of the HurriChem but with improved spatial drug distribution. Conclusion: The availability of new PIPAC nozzles is encouraging but can also have a negative impact if their performance and efficacy is unknown. It is recommended that PIPAC nozzles that deviate from the current standard should be subject to bioequivalence testing and implementation in accordance with the IDEAL-D framework prior to routine clinical use.

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“…Based on these results, PIPAC has been broadly adopted during the past decade, mainly in Europe. Recent reviews suggest that PIPAC is safe and feasible, and offers hope for patients with various types of peritoneal malignancies, although prospective controlled trials are necessary in the future [ 127 , 128 ].…”

Section: Intraperitoneal Route (I-pr)mentioning

confidence: 99%

Anatomical Targeting of Anticancer Drugs to Solid Tumors Using Specific Administration Routes: Review

et al. 2023

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Despite remarkable recent progress in developing anti-cancer agents, outcomes of patients with solid tumors remain unsatisfactory. In general, anti-cancer drugs are systemically administered through peripheral veins and delivered throughout the body. The major problem with systemic chemotherapy is insufficient uptake of intravenous (IV) drugs by targeted tumor tissue. Although dose escalation and treatment intensification have been attempted in order to increase regional concentrations of anti-tumor drugs, these approaches have produced only marginal benefits in terms of patient outcomes, while often damaging healthy organs. To overcome this problem, local administration of anti-cancer agents can yield markedly higher drug concentrations in tumor tissue with less systemic toxicity. This strategy is most commonly used for liver and brain tumors, as well as pleural or peritoneal malignancies. Although the concept is theoretically reasonable, survival benefits are still limited. This review summarizes clinical results and problems and discusses future directions of regional cancer therapy with local administration of chemotherapeutants.

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Pressurized intraperitoneal aerosol chemotherapy (PIPAC): updated systematic review using the IDEAL framework

Cited by 11 publications

References 147 publications

Performance of different nebulizers in clinical use for Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC)

Performance of different nebulizers in clinical use for Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC)

Comparative Analysis of Nebulizers in Clinical use for Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC)

Anatomical Targeting of Anticancer Drugs to Solid Tumors Using Specific Administration Routes: Review

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