98
Participants
Start Date
March 31, 2022
Primary Completion Date
September 30, 2025
Study Completion Date
September 30, 2028
FOLFOX and PIPAC
"A minilaparotomy is performed in the midline. A 5 mm balloon trocar is inserted under finger protection in the right side and the fascia of the minilaparotomy is closed. The abdomen is insufflated with CO2 and a second 10-12mm trocar is introduced under videoscope control in upper left side. Ascites volume is documented and removed sending a sample for cytological examination, an accurate exploratory laparoscopy is performed, possibly placing an additional 5 or 10-12 mmHg trocar, the Peritoneal Cancer Index is calculated. Multiple biopsies are performed in different abdominal quadrants. A nebulizer CAPNOPEN© is inserted into the upper left side trocar and fixed with a 45° angle. The drugs (Cisplatin 10.5 mg/m2 body surface in 150 mL; Doxorubicin 2.1 mg/m2 body surface in 50 mL) are then injected through remote control with a flow rate of 0.7 mL/sec with a pressure of 200 psi. After an aerosol exposure phase of 30min, the aerosol is evacuated via a closed waste system."
RECRUITING
AOUI Verona, Verona
Azienda Ospedaliera Universitaria Integrata Verona
OTHER