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Original Investigation
May 28, 2019

Effect of Laparoscopic vs Open Distal Gastrectomy on 3-Year Disease-Free Survival in Patients With Locally Advanced Gastric Cancer: The CLASS-01 Randomized Clinical Trial

Author Affiliations
  • 1Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, China
  • 2Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China
  • 3Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai, China
  • 4Key laboratory of Carcinogenesis and Translational Research, Ministry of Education, Gastrointestinal Cancer Center, Peking University Cancer Hospital and Institute, Beijing, China
  • 5Department of Gastrointestinal Surgery, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
  • 6Department of Gastrointestinal Surgery & Laboratory of Gastric Cancer, State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, China
  • 7Department of Gastrointestinal Surgery, the Cancer Hospital of Harbin Medical University, Harbin, China
  • 8Department of Gastrointestinal Surgery, the First Hospital, Jilin University, Changchun, China
  • 9Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
  • 10Department of General Surgery, Tangdu Hospital, Fourth Military Medical University, Xi’an, China
  • 11Department of Gastrointestinal Surgery, the Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China
  • 12Department of Gastrointestinal Oncological Surgery, Fujian Provincial Cancer Hospital, Fuzhou, China
  • 13Department of Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
  • 14Department of General Surgery, General Hospital of PLA, Beijing, China
  • 15Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou, China
JAMA. 2019;321(20):1983-1992. doi:10.1001/jama.2019.5359
Key Points

Question  Does laparoscopic distal gastrectomy yield inferior oncological outcomes to open distal gastrectomy for patients with locally advanced gastric cancer?

Findings  In this randomized clinical trial that included 1056 patients with clinically staged locally advanced gastric cancer, laparoscopic vs open distal gastrectomy resulted in a 3-year disease-free survival rate of 76.5% vs 77.8%, respectively, a difference that did not exceed the noninferiority margin of −10%.

Meaning  These findings support the use of laparoscopic gastrectomy for patients assessed as having locally advanced cancer preoperatively.


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 study was 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 point was 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 ∞, 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