Morbidity and Mortality of Laparoscopic vs Open Total Gastrectomy for Clinical Stage I Gastric Cancer: The CLASS02 Multicenter Randomized Clinical Trial.
机构：[1]Department of General Surgery, Fudan University, Shanghai, China[2]Union Hospital, Department of General Surgery, Fujian Medical University, Fuzhou, China[3]Department of General Surgery, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China江苏省人民医院[4]Beijing Cancer Hospital, Department of General Surgery, Peking University, Beijing, China[5]Renji Hospital, Department of General Surgery, Shanghai Jiao Tong University, Shanghai, China[6]Department of General Surgery, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China[7]Department of General Surgery, Chinese PLA General Hospital, Beijing, China[8]Shanghai Cancer Center, Department of General Surgery, Fudan University, Shanghai, China[9]West China Hospital, Department of General Surgery, Sichuan University, Chengdu, China四川大学华西医院[10]Nanfang Hospital, Department of General Surgery, Southern Medical University, Guangzhou, China[11]Department of General Surgery, The First Hospital Affiliated to AMU, Chongqing, China[12]Department of General Surgery, Guangdong General Hospital, Guangzhou, China广东省人民医院[13]Department of General Surgery, The First Hospital of Jilin University, Changchun, China[14]Department of Biostatistics, Fudan University School of Public Health, Shanghai, China
The safety of laparoscopic total gastrectomy (LTG) for the treatment of gastric cancer remains uncertain given the lack of high-level clinical evidence.
To compare the safety of LTG for clinical stage I gastric cancer with that of conventional open total gastrectomy (OTG).
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.
Eligible patients were randomized to LTG (n = 113) or OTG (n = 114) by an interactive web response system.
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.
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.
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.
ClinicalTrials.gov Identifier: NCT03007550.
基金：
This work was supported by
grants from Clinical Trial Fund of Zhongshan
Hospital (2016ZSLC13) and Johnson & Johnson
Medical Ltd (IIS MIP-2017-11).
第一作者机构：[1]Department of General Surgery, Fudan University, Shanghai, China
共同第一作者：
通讯作者：
通讯机构：[1]Department of General Surgery, Fudan University, Shanghai, China[*1]Zhongshan Hospital, Department of General Surgery, Fudan University, 180 Fenglin Rd, Shanghai 200032, China
推荐引用方式(GB/T 7714)：
Liu Fenglin,Huang Changming,Xu Zekuan,et al.Morbidity and Mortality of Laparoscopic vs Open Total Gastrectomy for Clinical Stage I Gastric Cancer: The CLASS02 Multicenter Randomized Clinical Trial.[J].JAMA ONCOLOGY.2020,6(10):1590-1597.doi:10.1001/jamaoncol.2020.3152.
APA：
Liu Fenglin,Huang Changming,Xu Zekuan,Su Xiangqian,Zhao Gang...&Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS).(2020).Morbidity and Mortality of Laparoscopic vs Open Total Gastrectomy for Clinical Stage I Gastric Cancer: The CLASS02 Multicenter Randomized Clinical Trial..JAMA ONCOLOGY,6,(10)
MLA：
Liu Fenglin,et al."Morbidity and Mortality of Laparoscopic vs Open Total Gastrectomy for Clinical Stage I Gastric Cancer: The CLASS02 Multicenter Randomized Clinical Trial.".JAMA ONCOLOGY 6..10(2020):1590-1597
医学