BMC medicine · 2025
Long-term oncological outcomes of indocyanine green fluorescence imaging-guided laparoscopic lymphadenectomy for gastric cancer: 5-year outcomes from the FUGES-012 randomized clinical trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Zhong Qing, Wu Dong, Liu Zhi-Yu, Shang-Guan Zhi-Xin, Huang Ze-Ning, Zhang Zhi-Quan, Qiu Tao-Yuan, Chen Jun-Yu, Jiang Yi-Ming, Lin Guang-Tan, Tang Yi-Hui, Li Ping, Xie Jian-Wei, Lin Jian-Xian, Zheng Chao-Hui, Chen Qi-Yue, Huang Chang-Ming
Аннотация
BACKGROUND: The clinical use of indocyanine green (ICG) in laparoscopic radical gastrectomy for gastric cancer remains at an exploratory stage.
METHODS: Participants with resectable gastric adenocarcinoma were randomly allocated in a 1:1 ratio. The primary outcome is the number of retrieved lymph nodes (LNs) and has been reported. Herein, we report the 5-year overall survival (OS) rate, 5-year disease-free survival (DFS) rate, and related recurrence patterns.
RESULTS: Total 258 patients (ICG group, 129; non-ICG group, 129) were included in the final per-protocol analysis. The 5-year OS and DFS rate of the ICG group were superior to those of the non-ICG group (all log-rank P < 0.05). After a 5-year follow-up, the ICG group had a considerably lower cumulative recurrence rate (26/129, 20.2%) than the non-ICG group (44/129, 34.1%) (Gray's test P = 0.011), with a risk difference of - 0.140. Stratified by recurrence types, the ICG group exhibited a notably lower cumulative incidence of locoregional recurrence in comparison to the non-ICG group (ICG vs. non-ICG: 1.6% vs. 7.8%; risk difference = - 0.062; Gray's test P = 0.019). Dynamic analysis revealed that, in comparison to the ICG group, the non-ICG group had an earlier peak time and higher peak hazard of overall recurrence (ICG vs. non-ICG: peak time: 13.9 vs. 13.1 months; peak hazard: 0.0065 vs. 0.0138). Furthermore, landmark analysis indicated that the early recurrence (within 2 years) rate in the non-ICG group was 26.8%, which was significantly higher than the 13.1% in the ICG group (P = 0.006).
CONCLUSIONS: ICG-guided lymphadenectomy not only significantly improved the 5-year OS and DFS but also noticeably reduced the cumulative incidence of early recurrence. These findings support the routine use of ICG fluorescence-guided lymphadenectomy in laparoscopic radical gastrectomy.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT03050879.
METHODS: Participants with resectable gastric adenocarcinoma were randomly allocated in a 1:1 ratio. The primary outcome is the number of retrieved lymph nodes (LNs) and has been reported. Herein, we report the 5-year overall survival (OS) rate, 5-year disease-free survival (DFS) rate, and related recurrence patterns.
RESULTS: Total 258 patients (ICG group, 129; non-ICG group, 129) were included in the final per-protocol analysis. The 5-year OS and DFS rate of the ICG group were superior to those of the non-ICG group (all log-rank P < 0.05). After a 5-year follow-up, the ICG group had a considerably lower cumulative recurrence rate (26/129, 20.2%) than the non-ICG group (44/129, 34.1%) (Gray's test P = 0.011), with a risk difference of - 0.140. Stratified by recurrence types, the ICG group exhibited a notably lower cumulative incidence of locoregional recurrence in comparison to the non-ICG group (ICG vs. non-ICG: 1.6% vs. 7.8%; risk difference = - 0.062; Gray's test P = 0.019). Dynamic analysis revealed that, in comparison to the ICG group, the non-ICG group had an earlier peak time and higher peak hazard of overall recurrence (ICG vs. non-ICG: peak time: 13.9 vs. 13.1 months; peak hazard: 0.0065 vs. 0.0138). Furthermore, landmark analysis indicated that the early recurrence (within 2 years) rate in the non-ICG group was 26.8%, which was significantly higher than the 13.1% in the ICG group (P = 0.006).
CONCLUSIONS: ICG-guided lymphadenectomy not only significantly improved the 5-year OS and DFS but also noticeably reduced the cumulative incidence of early recurrence. These findings support the routine use of ICG fluorescence-guided lymphadenectomy in laparoscopic radical gastrectomy.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT03050879.