Endpoints
PD
POSTOPERATIVE COMPLICATION, DISEASE, POSTOPERATIVE COMPLICATION
The primary objective is to evaluate the safety of PIPAC and is based on treatment-related AEs reported by the NCI CTCAE version 5.0. AEs were assessed every 4–6 weeks.Secondary objectives included evaluation of progression-free survival, postoperative complication rate and response by imaging, PCI on laparoscopy, or histologic changes. Postoperative complications were graded according to Clavien–Dindo classification and evaluated 4 weeks after each PIPAC procedure. Response evaluation was based on RECIST version 1.1 criteria by imaging as a change from baseline at 10 weeks and 18 weeks. PCI determination was made at the time of each laparoscopy, with complete response (CR) defined as PCI < 3 with negative histology on at least three peritoneal biopsies, partial response (PR) defined as PCI decreased by 4, and progressive disease (PD) defined as PCI increased by 4. PRGS was evaluated by multiple biopsies performed at each laparoscopy for PIPAC procedure.