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Abstract
Introduction. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a new method of regional chemotherapy. To date, there is no consensus on the safety of using PIPAC in combination with resection and reconstructive interventions in the surgical treatment of gastric cancer.
Materials and Methods. This safety analysis included 52 patients treated in the GASPACCO clinical trial protocol (ClinicalTrials.gov No. NCT04595929). Patients were randomized into 2 equal groups: control (24 patients) — perioperative chemotherapy followed by gastrectomy and D2 lymph node dissection; PIPAC group (28 patients) — perioperative chemotherapy, gastrectomy with D2 lymph node dissection and intraoperative aerosol chemotherapy (PIPAC) with drugs: Cisplatin at a dose of 7.5 mg/m² and Doxorubicin — 1.5 mg/m².
Results. There were no significant statistical differences in intraoperative parameters (blood loss, time of the surgery). There was no statistically significant difference in haematological, renal, hepatic and gastrointestinal toxicity on days 3 and 7 post-operatively according to CTCAE ver 5.0 criteria. There was a statistically significant difference in pain levels on day 1 - patients in the PIPAC group had higher pain levels than patients in the control group. The same number of complications were observed in both groups of patients.
Conclusion. Carrying out the PIPAC technique simultaneously with radical surgery is safe, feasible and can be performed in patients with locally advanced gastric cancer. The study is registered on ClinicalTrials.gov, No. NCT04595929.
References
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