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腹腔镜与开腹 D2 远端胃癌根治术治疗进展期胃癌的疗效比较：一项随机对照临床试验。

Morbidity and Mortality of Laparoscopic Versus Open D2 Distal Gastrectomy for Advanced Gastric Cancer: A Randomized Controlled Trial.

机构信息

Yanfeng Hu, Hao Liu, Jiang Yu, and Guoxin Li, Nanfang Hospital, Southern Medical University; Hongbo Wei, The Third Affiliated Hospital of Sun Yat-Sen University; Pingyan Chen, Southern Medical University, Guangzhou; Changming Huang, Chaohui Zheng, and Ping Li, Fujian Medical University Union Hospital; Mingang Ying, Fujian Provincial Cancer Hospital, Fuzhou; Yihong Sun and Fenglin Liu, Zhongshan Hospital, Fudan University; Hui Cao and Gang Zhao, Renji Hospital, Shanghai Jiao Tong University School of Medicine; Weiguo Hu, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai; Xiaohui Du, General Hospital of the People's Liberation Army; Xiangqian Su, Ziyu Li, and Jiadi Xing, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing; Jiankun Hu and Xinzu Chen, West China Hospital, Sichuan University, Chengdu; Yingwei Xue and Kuan Wang, The Affiliated Tumor Hospital of Harbin Medical University, Harbin; Jian Suo, The First Hospital, Jilin University, Changchun; Kaixiong Tao, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan; and Xianli He, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.

出版信息

J Clin Oncol. 2016 Apr 20;34(12):1350-7. doi: 10.1200/JCO.2015.63.7215. Epub 2016 Feb 22.

DOI:10.1200/JCO.2015.63.7215

PMID:26903580

Abstract

PURPOSE

The safety and efficacy of radical laparoscopic distal gastrectomy (LG) with D2 lymphadenectomy for the treatment of advanced gastric cancer (AGC) remain controversial. We conducted a randomized controlled trial to compare laparoscopic and conventional open distal gastrectomy with D2 lymph node dissections for AGC.

PATIENTS AND METHODS

Between September 2012 and December 2014, 1,056 patients with clinical stage T2-4aN0-3M0 gastric cancer were eligible for inclusion. They were randomly assigned to either the LG with D2 lymphadenectomy group (n = 528) or the open gastrectomy (OG) with D2 lymphadenectomy group (n = 528). Fifteen experienced surgeons from 14 institutions in China participated in the study. The morbidity and mortality within 30 days after surgery between the LG (n = 519) and the OG (n = 520) groups were compared on the basis of the modified intention-to-treat principle. Postoperative complications were stratified according to the Clavien-Dindo classification.

RESULTS

The compliance rates of D2 lymphadenectomy were similar between the LG and OG groups (99.4% v 99.6%; P = .845). The postoperative morbidity was 15.2% in the LG group and 12.9% in OG group with no significant difference (difference, 2.3%; 95% CI, -1.9 to 6.6; P = .285). The mortality rate was 0.4% for the LG group and zero for the OG group (difference, 0.4%; 95% CI, -0.4 to 1.4; P = .249). The distribution of severity was similar between the two groups (P = .314).

CONCLUSION

Experienced surgeons can safely perform LG with D2 lymphadenectomy for AGC.

摘要

目的

根治性腹腔镜远端胃切除术（LG）联合 D2 淋巴结清扫术治疗进展期胃癌（AGC）的安全性和有效性仍存在争议。我们进行了一项随机对照试验，比较腹腔镜和传统开腹 D2 淋巴结清扫术治疗 AGC 的效果。

患者和方法

2012 年 9 月至 2014 年 12 月，共有 1056 名临床 T2-4aN0-3M0 期胃癌患者符合纳入标准。他们被随机分配到 LG 联合 D2 淋巴结清扫组（n = 528）或开腹胃切除术（OG）联合 D2 淋巴结清扫组（n = 528）。中国 14 家机构的 15 名经验丰富的外科医生参与了这项研究。根据改良意向治疗原则，比较 LG（n = 519）和 OG（n = 520）两组术后 30 天内的发病率和死亡率。术后并发症按 Clavien-Dindo 分类分层。

结果

LG 和 OG 两组 D2 淋巴结清扫的符合率相似（99.4%对 99.6%；P =.845）。LG 组术后并发症发生率为 15.2%，OG 组为 12.9%，差异无统计学意义（差异，2.3%；95%可信区间，-1.9 至 6.6；P =.285）。LG 组死亡率为 0.4%，OG 组为 0（差异，0.4%；95%可信区间，-0.4 至 1.4；P =.249）。两组严重程度分布相似（P =.314）。