Safety and Effectiveness of High-Precision Hyperthermic Intraperitoneal Perfusion Chemotherapy in Peritoneal Carcinomatosis: A Real-World Study

Abstract

BackgroundHyperthermic intraperitoneal chemotherapy (HIPEC) has been reported to effectively control peritoneal carcinomatosis (PC) in various patient populations, but there is a lack of real-world data. This study aimed to examine the safety and effectiveness of HIPEC in patients with PC in a real-world setting.MethodsThis was a retrospective study of patients with PC treated with the high-precision BR-TRG-I type HIPEC device between December 2006 and December 2016. Vital signs during HIPEC and adverse events were recorded. Effectiveness was evaluated by total objective remission rate (ORR), which was based on ascites’ remission 4 weeks after HIPEC.ResultsA total of 1,200 patients were included. There were 518 males and 682 females, with a mean age of 58.6 ± 6.5 years (range, 32–76 years). Among the patients, 93.6% of the patients (1123/1200) successfully received the three sessions of HIPEC, 158 had massive ascites. The changes of vital signs during HIPEC were within acceptable ranges, and patients only had a transient fever and abdominal distension. Regarding the HIPEC-related complications, hemorrhage was observed in seven (0.6%) patients, anastomotic leakage in four (0.5%), and intestinal obstruction in eight (0.7%). Nine (0.8%, 9/1200) patients had CTCAE grade IV bone marrow suppression, and three (0.3%, 3/1200) patients had severe renal failure (SRF), which were considered to be drug-related. The ORR of malignant ascites was 95.6% (151/158).ConclusionThis real-world study strongly suggests that HIPEC was safe in treating PC patients with a low rate of adverse events and leads to benefits in PC patients with massive malignant ascites.

Comparative Sensing and Judgment Control System for Temperature Maintenance for Optimal Treatment in Hyperthermic Intraperitoneal Chemotherapy Surgery

“…Heat control methods (instantaneous heating) using temperature monitoring and control in HIPEC surgery include hot water and microwave (or high-frequency induction local heating thermal treatment) heating [ 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 ]. These methods suffer from low precision and unstable perfusion rate during temperature control [ 27 ].…”

“…Heat control methods (instantaneous heating) using temperature monitoring and control in HIPEC surgery include hot water and microwave (or high-frequency induction local heating thermal treatment) heating [ 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 ]. These methods suffer from low precision and unstable perfusion rate during temperature control [ 27 ]. Because maintaining stable heat input for at least 60 min during system operation is difficult, a method of controlling the temperature with continuous monitoring and proper control is essential [ 35 ].…”

“…To improve the precision of temperature control, efficiently controlling heat by comparing and judging a fitting result of mathematical modeling and a monitoring signal was developed. The control technology used a proportional–integral–differential controller (PID) with at least 95% accuracy and ±5% tolerance range [ 27 ]. Here, the time required by the TC module to determine T D and T ref is critical [ 35 ].…”

Risk factors of temperature increase after cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy

“…Different types of chemotherapy drug are independent risk factors for a temperature increase following HIPEC. In a multi-center HIPEC study carried out in China ( 8 ), the inflow temperature was set at 43°C and the perfusion duration was 90 min, and the patients’ recorded vital signs remained stabilized, with a sharp temperature increase and abdominal distension during HIPEC. After 30–90 min of perfusion, the patients’ heart rate, respiratory rate, and rectal temperature (as high as 39.7°C–40.2°C) were all above baseline level before returning to the baseline within 30 min following perfusion; however, the study did not discuss the effect on temperature increase by different chemotherapy drugs.…”

Validation of thermal dynamics during Hyperthermic IntraPEritoneal Chemotherapy simulations using a 3D-printed phantom

“…To achieve this, control over the thermal distribution is required which is difficult due to the large treatment volume and complicated dynamics and interactions. To represent intraperitoneal thermal distributions, studies often report on just inflow and outflow temperatures ( 11 , 12 ) or measurements at one (unknown) abdominal site. The assumption is that when thermal losses between inflow and outflow are minimal or when a critical temperature is reached, the thermal distribution is stable enough such that chemotherapeutics can be administered.…”