IMPORTANCE Laparoscopic distal gastrectomy is accepted as a more effective approach to conventional open distal gastrectomy for early-stage gastric cancer. However, efficacy for locally advanced gastric cancer remains uncertain.
OBJECTIVE To compare 3-year disease-free survival for patients with locally advanced gastric cancer after laparoscopic distal gastrectomy or open distal gastrectomy.
DESIGN, SETTING, AND PATIENTS The studywas a noninferiority, open-label, randomized clinical trial at 14 centers in China. A total of 1056 eligible patients with clinical stage T2, T3, or T4a gastric cancer without bulky nodes or distant metastases were enrolled from September 2012 to December 2014. Final follow-up was on December 31, 2017.
INTERVENTIONS Participants were randomized in a 1: 1 ratio after stratification by site, age, cancer stage, and histology to undergo either laparoscopic distal gastrectomy (n=528) or open distal gastrectomy (n=528) with D2 lymphadenectomy.
MAIN OUTCOMES AND MEASURES The primary end pointwas 3-year disease-free survival with a noninferiority margin of -10% to compare laparoscopic distal gastrectomy with open distal gastrectomy. Secondary end points of 3-year overall survival and recurrence patterns were tested for superiority.
RESULTS Among 1056 patients, 1039 (98.4%; mean age, 56.2 years; 313 [30.1%] women) had surgery (laparoscopic distal gastrectomy [n=519] vs open distal gastrectomy [n=520]), and 999 (94.6%) completed the study. Three-year disease-free survival rate was 76.5% in the laparoscopic distal gastrectomy group and 77.8% in the open distal gastrectomy group, absolute difference of -1.3% and a 1-sided 97.5% CI of -6.5% to infinity, not crossing the prespecified noninferiority margin. Three-year overall survival rate (laparoscopic distal gastrectomy vs open distal gastrectomy: 83.1% vs 85.2%; adjusted hazard ratio, 1.19; 95% CI, 0.87 to 1.64; P=.28) and cumulative incidence of recurrence over the 3-year period (laparoscopic distal gastrectomy vs open distal gastrectomy: 18.8% vs 16.5%; subhazard ratio, 1.15; 95% CI, 0.86 to 1.54; P=.35) did not significantly differ between laparoscopic distal gastrectomy and open distal gastrectomy groups.
CONCLUSIONS AND RELEVANCE Among patients with a preoperative clinical stage indicating locally advanced gastric cancer, laparoscopic distal gastrectomy, compared with open distal gastrectomy, did not result in inferior disease-free survival at 3 years.
TRIAL REGISTRATION ClinicalTrials. gov Identifier: NCT01609309
[1]Southern Med Univ, Nanfang Hosp, Dept Gen Surg, 1838 N Guangzhou Ave, Guangzhou 510515, Guangdong, Peoples R China;
[2]Fujian Med Univ, Union Hosp, Dept Gastr Surg, Fuzhou, Fujian, Peoples R China;
[3]Fudan Univ, Zhongshan Hosp, Dept Gen Surg, Shanghai, Peoples R China;
[4]Peking Univ Canc Hosp & Inst, Key Lab Carcinogenesis & Translat Res, Minist Educ, Gastrointestinal Canc Ctr, Beijing 100142, Peoples R China;
[5]Shanghai Jiao Tong Univ, Renji Hosp, Dept Gastrointestinal Surg, Sch Med, Shanghai, Peoples R China;
[6]Sichuan Univ, West China Hosp, Dept Gastrointestinal Surg, Chengdu, Sichuan, Peoples R China;
[7]Sichuan Univ, West China Hosp, Lab Gastr Canc, State Key Lab Biotherapy, Chengdu, Sichuan, Peoples R China;
[8]Harbin Med Univ, Canc Hosp, Dept Gastrointestinal Surg, Harbin, Heilongjiang, Peoples R China;
[9]Jilin Univ, Hosp 1, Dept Gastrointestinal Surg, Changchun, Jilin, Peoples R China;
[10]Huazhong Univ Sci & Technol, Tongji Med Coll, Union Hosp, Dept Gastrointestinal Surg, Wuhan, Hubei, Peoples R China;
[11]Fourth Mil Med Univ, Tangdu Hosp, Dept Gen Surg, Xian, Shaanxi, Peoples R China;
[12]Sun Yat Sen Univ, Affiliated Hosp 3, Dept Gastrointestinal Surg, Guangzhou, Guangdong, Peoples R China;
[13]Fujian Prov Canc Hosp, Dept Gastrointestinal Oncol Surg, Fuzhou, Fujian, Peoples R China;
[14]Shanghai Jiao Tong Univ, Sch Med, Ruijin Hosp, Dept Surg, Shanghai, Peoples R China;
[15]Gen Hosp PLA, Dept Gen Surg, Beijing, Peoples R China;
[16]Southern Med Univ, Sch Publ Hlth, Dept Biostatist, Guangzhou, Guangdong, Peoples R China;
[17]Guangdong Gen Hosp, Dept Gen Surg, Guangzhou, Guangdong, Peoples R China;
[18]Jilin Univ, Hosp 2, Dept Gen Surg, Changchun, Jilin, Peoples R China;
[19]Nanjing Mil Command, Nanjing Gen Hosp, Dept Gen Surg, Nanjing, Jiangsu, Peoples R China;
[20]Jiangsu Prov Hosp Chinese Med, Dept Gen Surg, Nanjing, Jiangsu, Peoples R China;
[21]First Peoples Hosp Foshan, Dept Gastrointestinal Surg, Foshan, Peoples R China;
[22]Xiamen Univ, Zhongshan Hosp, Dept Gastrointestinal Surg, Xiamen, Fujian, Peoples R China;
[23]Jiaozhou Cent Hosp Qingdao, Dept Gen Surg, Qingdao, Shandong, Peoples R China;
[24]Nanjing Med Univ, Affiliated Hosp 2, Dept Gen Surg, Nanjing, Jiangsu, Peoples R China
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