Five-year survival after minimally invasive versus open gastrectomy: A meta-analysis of randomized controlled trials with trial sequential analysis
Abstract
Background: Debates persist regarding long-term oncological safety of mini-invasive gastrectomy (MIG)compared to open gastrectomy (OG). KLASS-02 trial and CLASS-01 trial concluded to the absence of statistically significant difference in oncologic outcomes between the two approaches. This meta-analysis evaluates the 5-year survival outcomes of MIG versus OG with Trial Sequential Analysis (TSA).
Methods: A systematic literature search was conducted in Medline, Embase and Scopus. The primary endpoint was 5-year overall survival (OS), and secondary endpoints included stage-specific OS and 5-year disease-free survival (DFS). Risk ratios (RR) with 95% confidence intervals (CI) were pooled using a random-effects model. TSA was performed to estimate the robustness of the meta-analysis.
Results: Ten randomized trials were included. No significant difference in 5-year OS was observed between MIG and OG groups (RR = 1.009; 95% CI:0.994-1.025; p = 0.247; tau2 = 0). Subgroup analysis by TNM stage and meta-regression by percentage of total gastrectomies in the included trials confirmed long-term oncological safety of MIG irrespective of the TNM stage or the extent of the gastric resection. No significant statistical difference was observed for 5-year DFS (RR = 1.007; 95% CI:0.985-1.030; p = 0.514; tau2 = 0). TSA for 5-year OS demonstrated that the cumulative Z-curve crossed the futility boundaries and exceeded the required information size, confirming no statistical difference between…
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