Long-term survival outcomes of laparoscopic total gastrectomy vs open total gastrectomy in patients with clinical stage I gastric cancer: the CLASS02 randomized clinical trial
Year: 2026
Type: article
Study design: Clinical Trial
Abstract: BACKGROUND: The long-term survival outcomes for patients with clinical stage I gastric cancer who undergo laparoscopic total gastrectomy (LTG) are still uncertain due to the limited high-level clinical evidence. MATERIAL AND METHODS: The CLASS02 study was designed as a prospective, multicenter, open-label, randomized, non-inferiority clinical trial carried out across 14 gastroenterology centers in China. Patients diagnosed with clinical stage I gastric adenocarcinoma located in the middle and/or upper third of the stomach were randomly assigned to receive either LTG or open total gastrectomy (OTG) accompanied by D1+/D2 lymphadenectomy performed by skilled surgeons. Building on the primary analysis of safety results at 30 days, published in 2020, this extended analysis aimed to evaluate 5-year overall survival (OS) and disease-free survival (DFS) rates between LTG and OTG. RESULTS: Of the 227 patients who were enrolled between January 2017 and September 2018, 214 patients underwent total gastrectomy: 105 (49.0%) in the LTG group and 109 (51.0%) in the OTG group. The 5-year OS rate was 93.3% in the LTG group compared to 94.5% in the OTG group, and the 5-year DFS rate was 92.4% in the LTG group compared to 93.6% in the OTG group. There were no significant differences between the groups. CONCLUSION: Given the current underpowered long-term follow-up findings, LTG with D1 +/D2 lymphadenectomy performed by experienced surgeons showed numerically similar 5-year overall survival and disease-free survival rates to OTG in patients with clinical stage I gastric cancer.
Source: International Journal of Surgery
Institutions: Fudan University, Zhongshan Hospital, Fujian Medical University, Union Hospital, Jiangsu Province Hospital, Nanjing Medical University, Peking University, Peking University Cancer Hospital, Shanghai Jiao Tong University, Renji Hospital, First Affiliated Hospital of Fujian Medical University, Chinese PLA General Hospital, Fudan University Shanghai Cancer Center, Sichuan University, West China Medical Center of Sichuan University, West China Hospital of Sichuan University, Beijing Tsinghua Chang Gung Hospital, Tsinghua University, Guangdong General Hospital, First Hospital of Jilin University
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,450
OpenAlex ID: W7124855451