ImportanceSplenic hilar lymphadenectomy has been recommended for locally advanced proximal gastric cancer (APGC) involving the greater curvature. However, it is unclear whether laparoscopic spleen-preserving splenic hilar lymphadenectomy (LSPSHL) is associated with a long-term survival benefit for APGC without greater curvature invasion.ObjectiveTo present the 5-year follow-up data from a randomized clinical trial that compared laparoscopic total gastrectomy (D2 group) with D2 plus LSPSHL (D2 + No. 10 group) among patients with resectable APGC.Design, Setting, and ParticipantsThis is a post hoc secondary analysis of a randomized clinical trial that enrolled 536 patients with potentially resectable APGC (cT2-4a, N0 or N+, and M0) without greater curvature invasion from January 5, 2015, to October 10, 2018. All patients were tracked for at least 5 years. The final follow-up was on October 30, 2023.InterventionsPatients were randomly assigned in a 1:1 ratio to the D2 + No. 10 or D2 groups.Main Outcomes and MeasuresThe 5-year disease-free survival (DFS) and overall survival (OS) rates were measured. Recurrence patterns and causes of death were compared.ResultsA total of 526 patients (392 men [74.5%]; mean [SD] age, 60.6 [9.6] years) were included in the modified intent-to-treat analysis, with 263 patients in each group. The 5-year DFS rate was 63.9% (95% CI, 58.1%-69.7%) for the D2 + No. 10 group and 55.1% (95% CI, 49.1%-61.1%) for the D2 group (log-rank P = .04). A statistically significant difference was observed in the 5-year OS between the D2 + No. 10 group and the D2 group (66.2% [95% CI, 60.4%-71.9%] vs 57.4% [95% CI, 51.4%-63.4%]; log-rank P = .03). The No. 10 lymph node exhibited a therapeutic value index (TVI) of 6.5, surpassing that of Nos. 8a (TVI, 3.0), 11 (TVI, 5.8), and 12a (TVI, 0.8). A total of 86 patients in the D2 + No. 10 group (cumulative incidence, 32.7%) and 111 patients in the D2 group (cumulative incidence, 42.2%) experienced recurrence (hazard ratio, 0.72; 95% CI, 0.54-0.95; P = .02). The multivariable competing risk regression model demonstrated that D2 + No. 10 remained an independent protective factor for a lower 5-year cumulative recurrence rate after surgery (hazard ratio, 0.75; 95% CI, 0.56-1.00; P = .05). There was a significant difference in the 5-year cumulative recurrence rate at the No. 10 lymph node area between the 2 groups (D2 + No. 10 group vs D2 group: 0% vs 2.3% [n = 6]; P = .01).ConclusionsThis post hoc secondary analysis of a randomized clinical trial found that laparoscopic total gastrectomy with LSPSHL can improve the prognosis and reduce recurrence for APGC without greater curvature invasion. Future multicenter studies are warranted to validate these findings.Trial RegistrationClinicalTrials.gov Identifier: NCT02333721

中文翻译：

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腹腔镜保脾肺门淋巴结切除术治疗无大曲度侵袭的晚期近端胃癌

重要性 脾门淋巴结切除术被推荐用于累及大弯的局部晚期近端胃癌 (APGC)。然而，目前尚不清楚腹腔镜保脾脾门淋巴结切除术（LSPSHL）是否与无大弯侵犯的 APGC 的长期生存获益相关。目的展示一项比较腹腔镜手术的随机临床试验的 5 年随访数据可切除 APGC 患者中采用 D2 加 LSPSHL（D2 + No. 10 组）的全胃切除术（D2 组）。设计、设置和参与者这是一项随机临床试验的事后二次分析，该试验纳入了 536 名可能可切除 APGC 的患者（ 2015年1月5日至2018年10月10日期间，cT2-4a、N0或N+和M0）无大弯侵犯。所有患者均被跟踪至少5年。最后一次随访时间为2023年10月30日。干预措施将患者按1:1的比例随机分配至D2+10号或D2组。主要结果和指标5年无病生存率（DFS）和总生存率测量了（OS）率。比较复发模式和死亡原因。 结果 修改后的意向治疗分析共纳入 526 名患者（392 名男性 [74.5%]；平均 [SD] 年龄，60.6 [9.6] 岁），其中 263 名患者每组。 D2 + No.10 组的 5 年 DFS 率为 63.9%（95% CI，58.1%-69.7%），D2 组为 55.1%（95% CI，49.1%-61.1%）（对数秩）磷= .04)。 D2 + No.10 组和 D2 组之间的 5 年 OS 存在统计学显着差异（66.2% [95% CI, 60.4%-71.9%] vs 57.4% [95% CI, 51.4%-63.4] %];磷= .03)。 10号淋巴结的治疗价值指数（TVI）为6.5，超过8a号（TVI，3.0）、11号（TVI，5.8）和12a号（TVI，0.8）淋巴结。 D2+No.10组共有86名患者（累计发生率32.7%）和D2组111名患者（累计发生率42.2%）出现复发（风险比，0.72；95% CI，0.54-0.95；磷= .02)。多变量竞争风险回归模型表明，D2 + No.10 仍然是术后 5 年累积复发率较低的独立保护因素（风险比，0.75；95% CI，0.56-1.00；磷= .05)。 2组间10号淋巴结区5年累积复发率有显着差异（D2+10号组vs D2组：0% vs 2.3%[n=6]；磷= .01)。结论这项随机临床试验的事后二次分析发现，腹腔镜全胃切除术联合 LSPSHL 可以改善 APGC 的预后并减少复发，而无需更大的曲率侵犯。未来的多中心研究有必要验证这些发现。试验注册ClinicalTrials.gov 标识符：NCT02333721