Safety analysis of intraperitoneal hyperthermic chemotherapy in the treatment of gastrointestinal cancer: a systematic review and meta-analysis.

objectiveTo evaluate the safety of intraperitoneal hyperthermic perfusion chemotherapy in the treatment of gastrointestinal cancer by meta-analysis method.

methodsPubmed, Embase, WOS, Scopus, ScienceDirect and springer were retrieved by computer. Patients with gastrointestinal malignancies accompanied by peritoneal metastasis were selected as the research subjects, and randomized controlled trials (RCTs) of intraperitoneal hyperthermic perfusion chemotherapy were retrieved. The search time range covers all records in major databases from their establishment to January 2025, and traces the relevant references. Two researchers independently screened the references, extracted the corresponding materials respectively, and managed and extracted the data of the included references using Excel. Data analysis of the included references that met the requirements was conducted using R4.4.2 software. According to the guiding principles of the Cochrane Collaboration, for continuous variables in systematic reviews, weighted mean difference (MD) and its 95% confidence interval (CI) are usually used as effect indicators, while for binary variables, risk ratio (RR) is adopted, and 95% CI is used as the effect indicator. The heterogeneity of the included literature was determined through I2 analysis and Q verification. When P ≥ 0.1 and I2 ≤ 50%, the fixed-effect model was adopted. When P < 0.1 or I2 > 50%, the random effects model is adopted. The outcome observation indicators were: the incidence of severe adverse reactions, infection, anastomotic leakage, massive hemorrhage, intestinal obstruction, digestive tract adverse reactions (nausea, vomiting, diarrhea), pneumonia, neutropenia, etc.

resultsA total of 10 RCTs were included, with a total of 1060 patients participating in this study. The number of patients in the experimental group was 540, and the number of patients in the control group was 520. According to the results of the meta-analysis, compared with the control group, after the implementation of HIPEC (hyperthermic intraperitoneal chemotherapy), the incidence of serious adverse events (AE) with Grade ≥ 3 after surgery, intestinal obstruction, massive gastrointestinal bleeding, infection, digestive tract adverse reactions, pneumonia, and neutropenia in the experimental group did not show statistically significant differences(RR 1.05, 95% CI 0.94 to 1.18; I² = 42%). The incidence of adverse reactions related to anastomotic leakage in the experimental group was higher than that in the control group, but the result was not statistically significant (RR = 0.861, 95%CI (0.214, 3.459), Z = 0.21, P = 0.83).

conclusionCurrent evidence from RCTs does not show a clear increase in major postoperative complications with HIPEC in patients with gastrointestinal cancer and peritoneal metastasis (PM), suggesting it may be a safe option. However, the certainty of evidence is low to moderate. The specific efficacy of HIPEC still needs to be further evaluated. Whether it can increase the long-term survival rate of patients and prolong their survival period still requires multi-center, large-sample, and high-quality clinical studies to further demonstrate.