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

Abstract Purpose: 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.

Effectiveness of a reusable low-cost balloon trocar dissection device in the creation of preperitoneal space during endoscopic surgery. An experimental study in swine

PURPOSE: To evaluate a new, low-cost, reusable balloon trocar device for dissection of the preperitoneal space during endoscopic surgery.METHODS:Twenty swine (weight: 15-37 kg) were randomized to two groups, according to whether the preperitoneal space was created with a new balloon device manufactured by Bhio-Supply (group B) or with the commercially available OMSPDB 1000(r) balloon device manufactured by Covidien (group C). Quality and size of the created preperitoneal space, identification of anatomic structures, balloon dissection time, total procedure time, balloon resistance and internal pressure after insufflation with 300 mL of ambient air, balloon-related complications, and procedure cost were assessed.RESULTS:No significant differences in dissection time, total procedure time, or size of the created preperitoneal space were found between the groups. Balloons in group B had a significantly higher internal pressure compared to balloons in group C. None of the balloons ruptured during the experiment. Three animals in group C had balloon-related peritoneal lacerations. Despite a higher individual device cost, group B had a lower procedure cost over the entire experiment.CONCLUSION:The new balloon device is not inferior to the commercially available device in terms of the safety and effectiveness for creating a preperitoneal space in swine.