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首页> 外文期刊>Surgical Endoscopy >Short-term surgical outcomes of laparoscopy-assisted versus open D2 distal gastrectomy for locally advanced gastric cancer in North China: a multicenter randomized controlled trial
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Short-term surgical outcomes of laparoscopy-assisted versus open D2 distal gastrectomy for locally advanced gastric cancer in North China: a multicenter randomized controlled trial

机译：腹腔镜检查的短期外科辅助与North中国局部晚期胃癌的开放D2远端胃切除术：多中心随机对照试验

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摘要

BackgroundAlthough laparoscopic surgery has been recommended as an optional therapy for patients with early gastric cancer, whether patients with locally advanced gastric cancer (AGC) could benefit from laparoscopy-assisted distal gastrectomy (LADG) with D2 lymphadenectomy remains elusive due to a lack of comprehensive clinical data. To evaluate the efficacy of LADG, we conducted a multi-institutional randomized controlled trial to compare laparoscopy-assisted versus open distal gastrectomy (ODG) for AGC in North China.MethodsIn this RCT, after patients were enrolled according to the eligibility criteria, they were preoperatively assigned to LADG or ODG arm randomly with a 1:1 allocation ratio. The primary endpoint was the morbidity and mortality within 30 postoperative days to evaluate the surgical safety of LADG. The secondary endpoint was 3-year disease-free survival. This trial was registered at ClinicalTrial.gov as NCT02464215.ResultsBetween March 2014 and August 2017, a total of 446 patients with cT2-4aN0-3M0 (AJCC 7th staging system) were enrolled. Of these, 222 patients underwent LADG and 220 patients underwent ODG were included in the modified intention-to-treat analysis. The compliance rate of D2 lymph node dissection was identical between the LADG and ODG arms (99.5%, P=1.000). No significant difference was observed regarding the overall postoperative complication rate in two groups (LADG 13.1%, ODG 17.7%, P=0.174). No operation-related death occurred in both arms.ConclusionsThis trial confirmed that LADG performed by credentialed surgeons was safe and feasible for patients with AGC compared with conventional ODG.
机译：背景技术虽然腹腔镜手术被推荐为早期胃癌患者的可选治疗，无论患有局部晚期胃癌（AGC）的患者是否可以从腹腔镜辅助远端胃切除术（LADG）中受益于D2淋巴结切除术，由于缺乏综合临床，仍然难以实现数据。为了评估LADG的疗效，我们进行了一种多机构随机对照试验，以比较腹腔镜辅助与北方AGC的腹腔镜辅助胃切除术（ODG）。在患者根据资格标准招募患者后，他们是用1：1分配比随机分配给LADG或ODG臂。主要终点是术后日内的发病率和死亡率，以评估LADG的手术安全性。次要终点是3年无病生存期。该试验在ClinColicalTrial.gov注册为NCT02464215. 2014年3月和2017年8月，共有446例CT2-4AN0-3M0（AJCC第7次分期系统）。其中，222名患者接受了LADG和220名患者的接受了ODG的修正意向治疗分析。 LADG和ODG臂（99.5％，P = 1.000）之间的D2淋巴结解剖的顺从率相同。对于两组的整体术后并发症率没有显着差异（LADG 13.1％，ODG 17.7％，P = 0.174）。两者武器中没有发生任何与操作相关的死亡。结论性审判证实，通过常规ODG与AGC的患者患者进行了安全性和可行的LADG。

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  • 来源
    《Surgical Endoscopy》 |2019年第1期|共13页
  • 作者

    Wang Zaozao; Xing Jiadi; Cai Jun; Zhang Zhongtao; Li Fei; Zhang Nengwei; Wu Jixiang; Cui Ming; Liu Ying; Chen Lei; Yang Hong; Zheng Zhi; Wang Xiaohui; Gao Chongchong; Wang Zhe; Fan Qing; Zhu Yanlei; Ren Shulin; Zhang Chenghai; Liu Maoxing; Ji Jiafu; Su Xiangqian;

  • 作者单位

    Peking Univ Dept Gastrointestinal Surg 4 Key Lab Carcinogenesis &

    Translat Res Canc Hosp &

    Inst;

    Peking Univ Dept Gastrointestinal Surg 4 Key Lab Carcinogenesis &

    Translat Res Canc Hosp &

    Inst;

    Capital Med Univ Beijing Friendship Hosp Dept Gen Surg Beijing Key Lab Canc Invas &

    Metastasis;

    Capital Med Univ Beijing Friendship Hosp Dept Gen Surg Beijing Key Lab Canc Invas &

    Metastasis;

    Capital Med Univ Xuanwu Hosp Dept Gen Surg Beijing 100053 Peoples R China;

    Capital Med Univ Dept Gen Surg Peking Univ Sch Clin Med 9 Beijing Shijitan Hosp Beijing 100038;

    Capital Med Univ Beijing Tongren Hosp Dept Gen Surg Beijing 100730 Peoples R China;

    Peking Univ Dept Gastrointestinal Surg 4 Key Lab Carcinogenesis &

    Translat Res Canc Hosp &

    Inst;

    Peking Univ Dept Gastrointestinal Surg 4 Key Lab Carcinogenesis &

    Translat Res Canc Hosp &

    Inst;

    Peking Univ Dept Gastrointestinal Surg 4 Key Lab Carcinogenesis &

    Translat Res Canc Hosp &

    Inst;

    Peking Univ Dept Gastrointestinal Surg 4 Key Lab Carcinogenesis &

    Translat Res Canc Hosp &

    Inst;

    Capital Med Univ Beijing Friendship Hosp Dept Gen Surg Beijing Key Lab Canc Invas &

    Metastasis;

    Capital Med Univ Xuanwu Hosp Dept Gen Surg Beijing 100053 Peoples R China;

    Capital Med Univ Xuanwu Hosp Dept Gen Surg Beijing 100053 Peoples R China;

    Capital Med Univ Xuanwu Hosp Dept Gen Surg Beijing 100053 Peoples R China;

    Capital Med Univ Dept Gen Surg Peking Univ Sch Clin Med 9 Beijing Shijitan Hosp Beijing 100038;

    Capital Med Univ Dept Gen Surg Peking Univ Sch Clin Med 9 Beijing Shijitan Hosp Beijing 100038;

    Capital Med Univ Beijing Tongren Hosp Dept Gen Surg Beijing 100730 Peoples R China;

    Peking Univ Dept Gastrointestinal Surg 4 Key Lab Carcinogenesis &

    Translat Res Canc Hosp &

    Inst;

    Peking Univ Dept Gastrointestinal Surg 4 Key Lab Carcinogenesis &

    Translat Res Canc Hosp &

    Inst;

    Peking Univ Canc Hosp &

    Inst Key Lab Carcinogenesis &

    Translat Res Dept Gastrointestinal Surg;

    Peking Univ Dept Gastrointestinal Surg 4 Key Lab Carcinogenesis &

    Translat Res Canc Hosp &

    Inst;

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  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 诊断学;
  • 关键词

    Locally advanced gastric cancer; Laparoscopy-assisted distal gastrectomy; Open distal gastrectomy; Surgical outcomes; Clinical trial;

    机译：局部晚期胃癌;腹腔镜检查辅助远端胃切除术;开放远端胃切除术;手术结果;临床试验;

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