Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 25, 2025
Date Accepted: Sep 26, 2025
Efficacy of Preventive Pressurized Intraperitoneal Aerosolized Chemotherapy in Locally Advanced Gastric Cancer: A Protocol for a Prospective Controlled Trial
ABSTRACT
Background:
Gastric cancer is a serious health issue both globally and in Kazakhstan. Worldwide, it ranks fifth in incidence, with the highest rates found in East Asia, the Andes of South America, and Eastern Europe, while the lowest rates are in North America, Northern Europe, Africa, and Southeast Asia. Over 70% of cases occur in resource-limited countries. In Kazakhstan, gastric cancer ranks third in morbidity and second in mortality among the population of the Republic of Kazakhstan, representing a serious clinical and social problem. Annually, 1600 deaths from malignant gastric neoplasms are registered. Peritoneal carcinomatosis (PC) is considered one of the most severe complications of gastric cancer and has long been regarded as its terminal stage. The average life expectancy of patients with PC is only 3–6 months, reflecting a high mortality rate and the limited efficacy of current treatments.
Objective:
We hypothesize that the prophylactic use of pressurized intraperitoneal chemotherapy (PIPAC) may reduce the incidence of PC. The aim of this study is to evaluate the incidence of peritoneal carcinomatosis following prophylactic PIPAC in patients with gastric cancer. The primary goal of this research is to evaluate whether adding prophylactic PIPAC to standard treatment before neoadjuvant chemotherapy can reduce the incidence of peritoneal carcinomatosis in patients with locally advanced gastric cancer.
Methods:
This study is a single-center randomized controlled trial with a planned enrollment of 120 patients. All participants will be included in one of two groups: intervention group (PIPAC + perioperative chemotherapy + gastrectomy with D2 lymphadenectomy) or control group (perioperative chemotherapy + gastrectomy with D2 lymphadenectomy). The primary endpoint was the incidence of peritoneal carcinomatosis, and the secondary endpoints were overall survival (OS), recurrence-free survival (RFS), treatment-related adverse events, and personal satisfaction.
Results:
A study by Grass et al (2020) showed that PIPAC significantly improves survival rates in patients with peritoneal metastases of gastric origin compared to standard chemotherapy. The study authors suggest that neoadjuvant use of PIPAC may reduce the incidence of peritoneal carcinomatosis and improve long-term survival outcomes. The results of the review will provide key information on the practicality and viability of PIPAC as a prophylactic technique for private progression of gastric cancer.
Conclusions:
not applicable Clinical Trial: Registered in ClinicalTrials.gov (NCT06784765). Patient enrollment will commence in January 2025, with anticipated primary completion in December 2026.
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