CHIPOFIL: A pilot study assessing the feasibility of HIPEC without extracorporeal circuit

Abstract

Background: Heated intraperitoneal chemotherapy (HIPEC) is currently performed using an external circuit including a heating device and a pump. Available devices have several drawbacks in terms of costs, technique (flow surges due to blocked tubes) and staff safety, hindering a wider use. In a previous preclinical study conducted in animals, we placed a heating wire within the abdomen to achieve and maintain hyperthermia. Our results showed this technique is safe and effective. The present pilot study was conceived as the first use of such a device in humans, aiming to confirm its safety and efficacy. Methods: This was a pilot study designed to include 13 patients undergoing HIPEC. Two sets of the prototype were placed within the abdominal cavity, one in the supramesocolic and one in the inframesocolic space. The target temperature was 42-43 °C during 30-90 min according to the protocol defined for each patient. The time to set up, heat and dismantle was measured. All complications were recorded during the first postoperative year and evaluated by an independent committee. Results: Nine women and four men were included. The median time to set on the device was 25 min. The target temperature was obtained in a median of 14 min and maintained uniform and homogeneously distributed within the abdomen for the scheduled duration. A permanent stirring of the viscera was performed. No thermal injury or device-related complications were observed. There were two anastomotic leaks (only one requiring reoperation), two hemoperitoneum requiring reoperation, one evisceration and one gastroparesia. Conclusions: A heating cable within the peritoneal cavity can achieve safe, simple, fast and efficient HIPEC.