Abstract：
BACKGROUND: Laparoscopic distal gastrectomy (LDG) has become a common procedure for treating advanced gastric cancer (AGC) in China. However, there is uncertainty regarding its oncological outcomes compared to open distal gastrectomy (ODG). This study aims to compare the 3-year disease-free survival (DFS) rates among patients who underwent surgery for AGC in northern China.
METHODS: A multicenter, non-inferiority, open-label, parallel, randomized clinical trial was conducted to evaluate patients with AGC who were eligible for distal gastrectomy at five tertiary hospitals in North China. In this trial, patients were randomly assigned preoperatively to receive either LDG or ODG in a 1:1 allocation ratio. The primary endpoint was postoperative morbidity and mortality within 30 days and the secondary endpoint was the 3-year DFS rate. This trial has been registered at ClinicalTrials.gov (Identifier: NCT02464215).
RESULTS: A total of 446 patients were randomly allocated to LDG (n = 223) or ODG group (n = 223) between March 2014 and August 2017. After screening, a total of 214 patients underwent the open surgical approach, while 216 patients underwent laparoscopic surgery. The 3-year DFS rate was 85.9% for the LDG group and 84.72% for the ODG group, with no significant statistical difference (Hazard ratio 1.12; 95% CI 0.68-1.84, P = 0.65). Body mass index (BMI) < 25 kg/m2, advanced pathologic T4, and pathologic N2-3 category were confirmed as independent risk factors for DFS in the Cox regression.
CONCLUSIONS: In comparison to ODG, LDG with D2 lymphadenectomy yielded similar outcomes in terms of 3-year DFS rates among patients diagnosed with AGC.
METHODS: A multicenter, non-inferiority, open-label, parallel, randomized clinical trial was conducted to evaluate patients with AGC who were eligible for distal gastrectomy at five tertiary hospitals in North China. In this trial, patients were randomly assigned preoperatively to receive either LDG or ODG in a 1:1 allocation ratio. The primary endpoint was postoperative morbidity and mortality within 30 days and the secondary endpoint was the 3-year DFS rate. This trial has been registered at ClinicalTrials.gov (Identifier: NCT02464215).
RESULTS: A total of 446 patients were randomly allocated to LDG (n = 223) or ODG group (n = 223) between March 2014 and August 2017. After screening, a total of 214 patients underwent the open surgical approach, while 216 patients underwent laparoscopic surgery. The 3-year DFS rate was 85.9% for the LDG group and 84.72% for the ODG group, with no significant statistical difference (Hazard ratio 1.12; 95% CI 0.68-1.84, P = 0.65). Body mass index (BMI) < 25 kg/m2, advanced pathologic T4, and pathologic N2-3 category were confirmed as independent risk factors for DFS in the Cox regression.
CONCLUSIONS: In comparison to ODG, LDG with D2 lymphadenectomy yielded similar outcomes in terms of 3-year DFS rates among patients diagnosed with AGC.
摘要：
背景：腹腔镜远端胃切除术（LDG）在中国已成为治疗晚期胃癌（AGC）的常用方法。然而,与开腹远端胃切除术(ODG)相比,其肿瘤结局存在不确定性.这项研究旨在比较中国北方接受AGC手术的患者的3年无病生存率（DFS）。
方法：多中心，非自卑，开放标签，平行,我们在华北地区5家三级医院进行了随机临床试验,以评估有资格行远端胃切除术的AGC患者.在这次审判中,患者在术前按1:1的分配比例随机分配接受LDG或ODG.主要终点是术后30天内的发病率和死亡率，次要终点是3年DFS率。该试验已在ClinicalTrials.gov注册（标识符：NCT02464215）。
结果：2014年3月至2017年8月，共有446例患者被随机分配到LDG组（n=223）或ODG组（n=223）。筛选后,共有214名患者接受了开放手术入路，216例患者接受了腹腔镜手术。LDG组3年DFS率为85.9%,ODG组为84.72%,差异无统计学意义(危险比1.12;95%CI0.68-1.84,P=0.65)。在Cox回归中，体重指数（BMI）<25kg/m2，晚期病理T4和病理N2-3类别被证实为DFS的独立危险因素。
结论：与ODG相比，在诊断为AGC的患者中，D2淋巴结清扫术的LDG在3年DFS方面产生了相似的结果。
方法：多中心，非自卑，开放标签，平行,我们在华北地区5家三级医院进行了随机临床试验,以评估有资格行远端胃切除术的AGC患者.在这次审判中,患者在术前按1:1的分配比例随机分配接受LDG或ODG.主要终点是术后30天内的发病率和死亡率，次要终点是3年DFS率。该试验已在ClinicalTrials.gov注册（标识符：NCT02464215）。
结果：2014年3月至2017年8月，共有446例患者被随机分配到LDG组（n=223）或ODG组（n=223）。筛选后,共有214名患者接受了开放手术入路，216例患者接受了腹腔镜手术。LDG组3年DFS率为85.9%,ODG组为84.72%,差异无统计学意义(危险比1.12;95%CI0.68-1.84,P=0.65)。在Cox回归中，体重指数（BMI）<25kg/m2，晚期病理T4和病理N2-3类别被证实为DFS的独立危险因素。
结论：与ODG相比，在诊断为AGC的患者中，D2淋巴结清扫术的LDG在3年DFS方面产生了相似的结果。
