Laparoscopic versus open total gastrectomy for clinical stage I gastric cancer: Morbidity and mortality results from a prospective randomized multicenter controlled trial (CLASS02).

Authors

Fenglin Liu

Fenglin Liu

Zhongshan Hospital, Fudan University, Shanghai, China

Fenglin Liu , Changming Huang , Zekuan Xu , Xiangqian Su , Gang Zhao , Jianxin Ye , Xiaohui Du , Hua Huang , Jiankun Hu , Guoxin Li , Peiwu Yu , Yong Li , Jian Suo , Naiqing Zhao , Wei Zhang , Haojie Li , Hongyong He , Yihong Sun

Organizations

Zhongshan Hospital, Fudan University, Shanghai, China, Fujian Medical University Union Hospital, Fuzhou, China, Department of General Surgery, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China, Peking University Cancer Hospital & Institute, Beijing, China, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China, Department of General Surgery, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China, People's Liberation Army General Hospital, Beijing, China, Department of General Surgery, Fudan University Shanghai Cancer Center, Shanghai, China, West China Hospital, Sichuan University, Chengdu, China, Nanfang Hospital/ Southern Medical University, Guangzhou, China, Southwest Hospital, Third Military Medical University, Chongqing, China, Department of General Surgery, Guangdong General Hospital, Guangzhou, China, Bethune First Hospital of Jilin University, Changchun, China, Fudan University, Shanghai, China, ZhongShan Hospital, Fudan University, Shanghai, China

Research Funding

Other Foundation
Clinical Trial Fund of Zhongshan Hospital Fudan University (2016ZSLC13), Pharmaceutical/Biotech Company

Background: The safety of laparoscopic total gastrectomy (LTG) for the treatment of gastric cancer remains lack of clinical evidence. The aim of this study was to compare the safety of LTG for clinical stage I gastric cancer with the conventional open total gastrectomy (OTG). Methods: From January 2017 to September 2018, a total of 227 patients with clinical stage T1N0-1M0/T2N0M0 gastric cancer were enrolled in this clinical trial and randomly assigned to Laparoscopic Gastrectomy group (LG, n=113) or Open Gastrectomy group (OG, n=114). The morbidity and mortality within 30 days following surgery, the recovery course, and the postoperative hospital stay between LG group (n=105) and OG group (n=109) were compared. Clavien-Dindo classification system was used to stratify surgical complications. Results: The overall morbidity rate was not significantly different in each group (LG group: 19.05%; OG group: 20.18%; Rate difference [RD]: -1.14%, 95%CI, -11.75%-9.58%). Intraoperative complications occurred in 3 (2.86%) patients in LG group and 4 (3.67%) patients in OG group (RD: -0.81%, 95%CI, -6.52%-4.85%). In addition, there was no significant difference in the overall postoperative complication rate of 18.10% in LG group and 17.43% in OG group (RD: 0.66%, 95%CI, -9.61%-11.01%). Each subtypes of postoperative complication were not significantly different between groups. One patient in LG group died of intra-abdominal bleeding from splenic artery, and there was no significant difference in mortality between LG group and OG group (RD: 0.95%, 95%CI, -2.54%-5.20%). The distribution of severity was similar between the two groups. Conclusions: Experienced surgeons can safely perform LTG with lymphadenectomy for clinical stage I gastric cancer. Clinical trial information: NCT03007550

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Abstract Details

Meeting

2020 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session A: Esophageal and Gastric Cancer and Other GI Cancers

Track

Esophageal and Gastric Cancer,Other GI Cancer

Sub Track

Therapeutics

Clinical Trial Registration Number

NCT03007550

Citation

J Clin Oncol 38, 2020 (suppl 4; abstr 378)

Abstract #

378

Poster Bd #

E11

Abstract Disclosures