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.
背景:对于局部进展期胃癌患者,微创远端胃切除术相较于开腹远端胃切除术已被证实能改善短期预后,但其对患者长期生存的影响仍存争议。本研究旨在比较两种术式对长期生存的影响。方法:对随机对照试验进行系统综述与试验序贯分析。检索数据库包括Web of Science、Scopus、MEDLINE、Cochrane Central Library及ClinicalTrials.gov。采用风险比及其95%置信区间作为合并效应量指标,主要结局指标为5年总生存期与无病生存期。结果:共纳入5项随机对照试验(2835例患者),其中微创手术组1421例(50.1%),开腹手术组1414例(49.9%)。患者年龄范围为48-70岁,男性占比63.4%。荟萃分析显示两组5年总生存期(HR=0.86;95%CI 0.70-1.04;I²=0.0%)与5年无病生存期(HR=1.03;95%CI 0.87-1.23;I²=0.0%)无显著差异。试验序贯分析显示累积Z曲线未跨越监测边界线(Z=1.96),提示因总信息量不足,当前5年生存数据尚不能得出确定性结论。结论:对于局部进展期胃癌患者,微创与开腹远端胃切除术可能具有相当的5年生存结局,但试验序贯分析表明现有证据总量尚不足以提供确定性结论。