A prototype single-port device for pressurized intraperitoneal aerosol chemotherapy. Technical feasibility and local drug distribution

Abstract

A prototype single-port device for pressurized intraperitoneal aerosol chemotherapy. Technical feasibility and local drug distribution 1 AbstractPurpose: To evaluate the technical feasibility and homogeneity of drug distribution of pressurized intraperitoneal aerosol chemotherapy (PIPAC) based on a novel process of intraperitoneal drug application (multidirectional aerosolization). Methods:This was an in vivo experimental study in pigs. A single-port device was manufactured at the smallest diameter possible for multidirectional aerosolization of the chemotherapeutic drug under positive intraperitoneal pressure. Four domestic pigs were used in the study, one control animal that received multidirectional microjets of 9 mL/sec for 30 min and three animals that received multidirectional aerosolization (pig 02: 9 mL/sec for 30 min; pigs 03 and 04: 3 mL/sec for 15 min). Aerosolized silver nitrate solution was applied for anatomopathological evaluation of intraperitoneal drug distribution. Results: Injection time was able to maintain the pneumoperitoneum pressure below 20 mmHg. The rate of moderate silver nitrate staining was 45.4% for pig 01, 36.3% for pig 02, 36.3% for pig 03, and 72.7% for pig 04. Conclusions: Intra-abdominal drug distribution had a broad pattern, especially in animals exposed to the drug for 30 min. Our sample of only four animals was not large enough to demonstrate an association between aerosolization and a higher silver nitrate concentration in the stained abdominal regions.

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

“…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 .…”

“…Analysis of the aerosol has shown that the droplet size is heterogeneous. One group has developed and brought to market a second device to enable PIPAC, but there is currently little information on the technical performance of this device, nor on its use outside Brazil.…”

Pressurized Intra-peritoneal Aerosol Chemotherapy (PIPAC)viaEndoscopical Microcatheter System

“…With regard to the latest published studies, it is known today that aerosol-creation and application into the peritoneal cavity is neither biologically nor technically restricted to the MIP ® (18,22,25). The creation of new aerosol-producing devices is becoming increasingly popular in contemporary research (18,26). With regards to untrained personnel, high costs and uncertainty in the handling of PIPAC with MIP ® , this study aimed to investigate a new option to apply PIPAC using of a well-known FDA-approved MC which has been utilized in gastroenterology and pulmonary medicine for years.…”

“…Furthermore, concerns of having no hands-on and clinical experience in handling the technology and potential difficulties might intimidate surgeons from applying PIPAC. Therefore, alternative aerosol-generating devices are developed and examined to meet these concerns (18,25,26). Current difficulties with these new and recently published prototype devices include that these are even less investigated than the original (MIP ® ).…”

Safety and efficacy of pressurized intraperitoneal/intrathoracic aerosol chemotherapy (PIPAC/PITAC) in patients with peritoneal and/or pleural carcinomatosis: A preliminary experience

“…Parallel to the population studies, research is progressing in order to improve the procedures, as seen in publications by Khosrawipour et al, [17] and Seitenfus et al, [21][22][23].…”