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
Department of Gastric Surgery, Fujian Medical University Union Hospital, Fuzhou, China.
Key Laboratory of Gastrointestinal Cancer (Fujian Medical University), Ministry of Education, Fuzhou, China.
BMC Med. 2025 Aug 26;23(1):497. doi: 10.1186/s12916-025-04334-1.
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.
吲哚菁绿（ICG）在腹腔镜胃癌根治术中的临床应用仍处于探索阶段。
将可切除的胃腺癌患者按1:1比例随机分配。主要结局指标为获取的淋巴结数量，该指标已有报道。在此，我们报告5年总生存率（OS）、5年无病生存率（DFS）及相关复发模式。
最终符合方案分析纳入258例患者（ICG组129例；非ICG组129例）。ICG组的5年OS和DFS率均优于非ICG组（所有对数秩检验P<0.05）。经过5年随访，ICG组的累积复发率（26/129，20.2%）显著低于非ICG组（44/129，34.1%）（Gray检验P=0.011），风险差为-0.140。按复发类型分层，与非ICG组相比，ICG组局部区域复发的累积发生率显著更低（ICG组与非ICG组：1.6%对7.8%；风险差=-0.062；Gray检验P=0.019）。动态分析显示，与ICG组相比，非ICG组总体复发的峰值时间更早且峰值风险更高（ICG组与非ICG组：峰值时间：13.9对13.1个月；峰值风险：0.0065对0.0138）。此外，界标分析表明，非ICG组的早期复发（2年内）率为26.8%，显著高于ICG组的13.1%（P=0.006）。
ICG引导下的淋巴结清扫不仅显著提高了5年OS和DFS，还明显降低了早期复发的累积发生率。这些发现支持在腹腔镜胃癌根治术中常规使用ICG荧光引导下的淋巴结清扫。
ClinicalTrials.gov，NCT03050879。
