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
Qing Zhong, Dong Wu, Zhiyu Liu, Zhi‐Xin Shang‐Guan, Ze‐Ning Huang, Zhiquan Zhang, Tao-yuan Qiu, Junyu Chen, Yiming Jiang, Guang-tan Lin, Yi-hui Tang, Ping Li, Jian-Wei Xie, Jian-Xian Lin, Chao‐Hui Zheng, Qi‐Yue Chen, Chang‐Ming Huang
Abstract
The clinical use of indocyanine green (ICG) in laparoscopic radical gastrectomy for gastric cancer remains at an exploratory stage. 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. 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). 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. ClinicalTrials.gov, NCT03050879. Can indocyanine green (ICG) fluorescence imaging-guided laparoscopic lymphadenectomy during laparoscopic radical gastrectomy in patients with gastric cancer improve the long-term oncological outcomes than conventional lymphadenectomy? In this randomized clinical trial, 5-year OS, DFS, and cumulative incidence of recurrence were better in the ICG group compared with the non–ICG group. ICG fluorescence imaging-guided lymphadenectomy not only significantly improved the 5-year OS and DFS but also noticeably reduced the recurrence hazard. The routine application of ICG fluorescence-guided lymphadenectomy is recommended for laparoscopic radical gastrectomy.