Description of a novel approach for intraperitoneal drug delivery and the related device

Solaß, Wiebke; Hetzel, Alexander; Nadiradze, Giorgi; Sagynaliev, Emil; Ma, Rong

doi:10.1055/s-0031-1289059

Cited by 33 publications

(56 citation statements)

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“…Overall, the search identified: 23 stage 0 studies; 18 stage 1 studies and two protocol papers for stage 1 studies; 25 stage 2a studies, one protocol paper and five trial registrations (NCT01854255, NCT02735928, NCT03246321, NCT02604784 and NCT03124394) for stage 2a studies; six stage 2b studies and three protocol papers for stage 2b studies; and three protocol papers for stage 3 studies. Fig .…”

Section: Resultsmentioning

confidence: 99%

“…The first studies investigating the technique used methylene blue dye, allowing visual assessment of the distribution and penetration of the aerosol versus lavage in an in vivo pig model. Distribution of the dye was observed to be superior for aerosolization, although this was assessed by visual inspection.…”

Section: Resultsmentioning

confidence: 99%

“…Pressurized intraperitoneal aerosol chemotherapy (PIPAC) for peritoneal metastases is a laparoscopic procedure used to assess the burden of the peritoneal disease, take biopsies, and deliver intraperitoneal chemotherapy as an aerosol, without increasing the intra-abdominal pressure 6 . Intraperitoneal administration of chemotherapy for peritoneal metastases from ovarian cancer was developed in the 1970s 7 and has subsequently been used for many different cancer types in the context of heated intraperitoneal chemotherapy (HIPEC) and early postoperative intraperitoneal chemotherapy (EPIC) 8 .…”

Section: Introductionmentioning

confidence: 99%

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

Tate

Torkington

2020

BJS Open

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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.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Tate

Torkington

2020

BJS Open

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“…Known limitations to HIPEC include unequal drug distribution and poor penetration of the chemotherapy into peritoneal tissues . Some centers, particularly in Europe, have introduced a novel technique to combat these limitations . PIPAC has been shown in preclinical models to allow higher local penetration of chemotherapy with low systemic toxicity …”

Section: Pressurized Intraperitoneal Aerosol Chemotherapymentioning

confidence: 99%

Treatment of metastatic colorectal cancer: innovations in surgical techniques

Andrade

Warner

Fong

2019

Journal of Surgical Oncology

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Liver metastases and peritoneal carcinomatosis are a particular focus of surgeons in improving survival in stage IV colorectal cancer patients, with laparotomy long being the means to undertake these operations. The Louisville statement published in 2008 was the first international consensus on indications for minimally invasive liver resection. Herein we review the progress in innovative surgical techniques, including minimally invasive liver resection, robot‐assisted hepatectomy, and we also describe initial reports in pressurized intraperitoneal aerosol chemotherapy.

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“…The PRGS is potentially clinically important in the assessment of histological response to intraperitoneal chemotherapy, particularly when such a therapy is given several times and the decision as to whether the patient should receive additional treatment depends on the histological response. A novel example of such a treatment is the pressurised intraperitoneal aerosol chemotherapy (PIPAC), where chemotherapeutics are aerosolised within the peritoneal cavity during a standard laparoscopy at a capnoperitoneum . Currently, PIPAC is an experimental treatment, and randomised, controlled trials are lacking at present .…”

Section: Introductionmentioning

confidence: 99%

Reproducibility of the peritoneal regression grading score for assessment of response to therapy in peritoneal metastasis

et al. 2019

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Aims The four‐tiered peritoneal regression grading score (PRGS) assesses the response to chemotherapy in peritoneal metastasis (PM). The PRGS is used, for example, to assess the response to pressurised intraperitoneal aerosol chemotherapy (PIPAC). However, the reproducibility of the PRGS is currently unknown. We aimed to evaluate the inter‐ and intraobserver variability of the PRGS. Methods and results Thirty‐three patients who underwent at least three PIPAC treatments as part of the PIPAC‐OPC1 or PIPAC‐OPC2 clinical trials at Odense University Hospital, Denmark, were included. Prior to each therapy cycle, peritoneal quadrant biopsies were obtained and three haematoxylin and eosin (H&E)‐stained step sections were scanned and uploaded to a pseudonymised web library. For determining interobserver variability, eight pathologists assessed the PRGS for each quadrant biopsy, and Krippendorff's alpha and intraclass correlation coefficients (ICCs) were calculated. For determining intraobserver variability, three pathologists repeated their own assessments and Cohen's kappa and ICCs were calculated. A total of 331 peritoneal biopsies were analysed. Interobserver variability for PRGS of each biopsy and for the mean and maximum PRGS per biopsy set was moderate to good/substantial. The intraobserver variability for PRGS of each biopsy and for the mean and maximum PRGS per biopsy set was good to excellent/almost perfect. Conclusions Our data support the PRGS as a reproducible and useful tool to assess response to intraperitoneal chemotherapy in PM. Future studies should evaluate the prognostic and predictive role of the PRGS.

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Description of a novel approach for intraperitoneal drug delivery and the related device

Cited by 33 publications

References 0 publications

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

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

Treatment of metastatic colorectal cancer: innovations in surgical techniques

Reproducibility of the peritoneal regression grading score for assessment of response to therapy in peritoneal metastasis

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