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Original Investigation
August 20, 2020

Morbidity and Mortality of Laparoscopic vs Open Total Gastrectomy for Clinical Stage I Gastric Cancer: The CLASS02 Multicenter Randomized Clinical Trial

Author Affiliations
  • 1Zhongshan Hospital, Department of General Surgery, Fudan University, Shanghai, China
  • 2Union Hospital, Department of General Surgery, Fujian Medical University, Fuzhou, China
  • 3Department of General Surgery, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China
  • 4Beijing Cancer Hospital, Department of General Surgery, Peking University, Beijing, China
  • 5Renji Hospital, Department of General Surgery, Shanghai Jiao Tong University, Shanghai, China
  • 6Department of General Surgery, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China
  • 7Department of General Surgery, Chinese PLA General Hospital, Beijing, China
  • 8Shanghai Cancer Center, Department of General Surgery, Fudan University, Shanghai, China
  • 9West China Hospital, Department of General Surgery, Sichuan University, Chengdu, China
  • 10Nanfang Hospital, Department of General Surgery, Southern Medical University, Guangzhou, China
  • 11Department of General Surgery, The First Hospital Affiliated to AMU, Chongqing, China
  • 12Department of General Surgery, Guangdong General Hospital, Guangzhou, China
  • 13Department of General Surgery, The First Hospital of Jilin University, Changchun, China
  • 14Department of Biostatistics, Fudan University School of Public Health, Shanghai, China
JAMA Oncol. 2020;6(10):1590-1597. doi:10.1001/jamaoncol.2020.3152
Key Points

Question  Is the safety of laparoscopic total gastrectomy for the treatment of clinical stage I gastric cancer noninferior to that of open total gastrectomy?

Findings  In this multicenter, open-label, noninferiority, randomized clinical trial of 227 patients with clinical stage I gastric cancer, the overall morbidity and mortality rates were 19.1% in the laparoscopic total gastrectomy group and 20.2% in the open total gastrectomy group, which was not significantly different (rate difference, −1.1%). There were no significant differences in rates of postoperative complications between the 2 groups.

Meaning  Experienced surgeons can perform laparoscopic total gastrectomy as safely as open total gastrectomy for clinical stage I gastric cancer.

Abstract

Importance  The safety of laparoscopic total gastrectomy (LTG) for the treatment of gastric cancer remains uncertain given the lack of high-level clinical evidence.

Objective  To compare the safety of LTG for clinical stage I gastric cancer with that of conventional open total gastrectomy (OTG).

Design, Setting, and Participants  The Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group CLASS02 study was a prospective, multicenter, open-label, noninferiority, randomized clinical trial that compared the safety of LTG vs OTG with lymphadenectomy for patients with clinical stage I gastric cancer. From January 2017 to September 2018, a total of 227 patients were enrolled. Final follow-up was in October 2018.

Interventions  Eligible patients were randomized to LTG (n = 113) or OTG (n = 114) by an interactive web response system.

Main Outcomes and Measures  The primary outcome was the morbidity and mortality within 30 days following surgeries between LTG and OTG with a noninferiority margin of 10%. The secondary outcomes were recovery courses and postoperative hospital stays.

Results  A total of 214 patients were analyzed for morbidity and mortality (105 patients in the LTG group and 109 patients in the OTG group). The mean (SD) age was 59.8 (9.4) years in the LTG group and 59.4 (9.2) years in the OTG group, and most were male (LTG group, 75 of 105 [71.4%]; OTG group, 80 of 109 [73.4%]). The overall morbidity and mortality rates were not significantly different between the groups (rate difference, −1.1%; 95% CI, −11.8% to 9.6%). Intraoperative complications occurred in 3 patients (2.9%) in the LTG group and 4 patients (3.7%) in the OTG group (rate difference, −0.8%; 95% CI, −6.5% to 4.9%). In addition, there was no significant difference in the overall postoperative complication rate of 18.1% in the LTG group and 17.4% in the OTG group (rate difference, 0.7%; 95% CI, −9.6% to 11.0%). One patient in the LTG group died from intra-abdominal bleeding secondary to splenic artery hemorrhage. However, there was no significant difference in mortality between the LTG group and the OTG group (rate difference, 1.0%; 95% CI, −2.5% to 5.2%), and the distribution of complication severity was similar between the 2 groups.

Conclusions and Relevance  The results of the CLASS02 trial showed that the safety of LTG with lymphadenectomy by experienced surgeons for clinical stage I gastric cancer was comparable to that of OTG.

Trial Registration  ClinicalTrials.gov Identifier: NCT03007550

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    1 Comment for this article
    Concerns about the sample size
    Rui Luo, na | Medical College of Nanchang Univeristy
    As described in the "Sample Size" section, the morbidity and mortality rates were assumed to be 20% in OTG groupand 15% in the LTG group. Setting 1-sided α of .025, β of .2, and the non-inferiority margin δ of 10%. When I was checking the sample calculation in the "Non-inferiority Tests for Two Proportions" module with PASS11, a total sample of 396 with 198 in per group was met.
    CONFLICT OF INTEREST: None Reported
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