First clinical evaluation report of using the Topol device to deliver PIPAC treatment

Abstract

Pressure Intra Peritoneal Aerosol Chemotherapy (PIPAC) is a new approach to deliver a drug into the peritoneal cavity. This novel approach associates an intraperitoneal pressure obtained by the laparoscopic procedure and an aerosol distribution obtained by a specific devoted nebulizer device. A new device is now available to perform PIPAC, called Topol® (Skala). We reported earlier, as a clinical evaluation report, the first consecutive cases treated. Seven patients had gastric, appendix, ovarian and rectal peritoneal metastasis and received 12 PIPAC procedures. The injector flow was selected to be 1.5 ml/s, as proposed by the company. No abnormal hyper pressure was observed in the injector. All the procedures were successful with a pressure between 10 and 20 bars and were performed to completion for drug administration. The intended therapeutic results were obtained in each case. No adverse events were recorded during the post-PIPAC clinical evaluations. To date, two patients succumbed due to peritoneal metastasis progression, 5 are alive, and two patients considered as non-operable had been secondarily proposed for cytoreductive surgery because of tumor response. One patient underwent gastrectomy, cytoreductive surgery and HIPEC. Conclusions regarding safety, performance and conformity are favorable for this first limited clinical evaluation report.