Minimally Invasive Versus Open Distal Gastrectomy for Locally Advanced Gastric Cancer: Trial Sequential Analysis of Randomized Trials

Background: Minimally invasive distal gastrectomy (MIDG) has been shown to be associated with improved short-term outcomes compared to open distal gastrectomy (ODG) in patients with locally advanced gastric cancer (LAGC). The impact of MIDG on long-term patient survival remains debated. Aim was to compare the MIDG vs. ODG effect on long-term survival. Methods: Systematic review and trial sequential analysis (TSA) of randomized controlled trials (RCTs). Web of Science, Scopus, MEDLINE, the Cochrane Central Library, and ClinicalTrials.gov were queried. Hazard ratio (HR) and 95% confidence intervals (CI) were used as pooled effect size measures. Five-year overall (OS) and disease-free survival (DFS) were primary outcomes. Results: Five RCTs were included (2835 patients). Overall, 1421 (50.1%) patients underwent MIDG and 1414 (49.9%) ODG. The ages ranged from 48 to 70 years and 63.4% were males. The pooled 5-year OS (HR = 0.86; 95% CI 0.70-1.04; I2 = 0.0%) and 5-year DFS (HR = 1.03; 95% CI 0.87-1.23; I2 = 0.0%) were similar for MIDG vs. ODG. The TSA shows a cumulative z-curve without crossing the monitoring boundaries line (Z = 1.96), thus suggesting not conclusive 5-year OS and DFS results because the total information size was not sufficient. Conclusions: MIDG and ODG seem to have equivalent 5-year OS and DFS in patients with LAGC. However, the cumulative evidence derived from the TSA showed that the actual information size is not sufficient to provide conclusive data.