Journal Article

Indocyanine green fluorescence imaging-guided versus conventional laparoscopic lymphadenectomy for gastric cancer: long-term outcomes of a phase 3 randomised clinical trial

Huang, Ze-Ning, Lin, Guang-Tan, Wang, Hua-Gen, Zheng, Chao-Hui, Li, Ping, Lin, Mi, Xu, Kai-Xiang, Zeng, Gui-Rong, Chen, Qi-Yue, Zheng, Qiao-Ling, Huang, Chang-Ming, Li, Yi-Fan, Wang, Jia-Bin, Tu, Ru-Hong, Zhong, Qing, Lin, Jian-Xian, Lu, Jun, Xie, Jian-Wei, Huang, Xiao-Bo, Liu, Zhi-Yu, Jiang, Mei-Chen, Cao, Long-Long

2023

Overview

Indocyanine green (ICG) fluorescence imaging-guided lymphadenectomy has been demonstrated to be effective in increasing the number of lymph nodes (LNs) retrieved in laparoscopic gastrectomy for gastric cancer (GC). Previously, we reported the primary outcomes and short-term secondary outcomes of a phase 3, open-label, randomized clinical trial (NCT03050879) investigating the use of ICG for image-guided lymphadenectomy in patients with potentially resectable GC. Patients were randomly (1:1 ratio) assigned to either the ICG or non-ICG group. The primary outcome was the number of LNs retrieved and has been reported. Here, we report the primary outcome and long-term secondary outcomes including three-year overall survival (OS), three-year disease-free survival (DFS), and recurrence patterns. The per-protocol analysis set population is used for all analyses (258 patients, ICG [n = 129] vs. non-ICG group [n = 129]). The mean total LNs retrieved in the ICG group significantly exceeds that in the non-ICG group (50.5 ± 15.9 vs 42.0 ± 10.3, P  < 0.001). Both OS and DFS in the ICG group are significantly better than that in the non-ICG group (log-rank P  = 0.015; log-rank P  = 0.012, respectively). There is a difference in the overall recurrence rates between the ICG and non-ICG groups (17.8% vs 31.0%). Compared with conventional lymphadenectomy, ICG guided laparoscopic lymphadenectomy is safe and effective in prolonging survival among patients with resectable GC. Due to high rate of metastasis, lymphadenectomy is a cornerstone of the surgical treatment of gastric cancer however the accurate dissection of lymph nodes (LN) can be challenging. Here, the authors present the long-term outcomes of a randomised control trial investigating indocyanine green fluorescence image-guided LN retrieval in gastric cancer patients undergoing laparoscopic gastrectomy.

• Publisher: Nature Publishing Group UK,Nature Publishing Group,Nature Portfolio
• Subject: 692/4020/1503/1504/1829 / 692/4028/546 / Cancer / Clinical trials / Fluorescence / Gastrectomy / Gastric cancer / Gastrointestinal surgery / Humanities and Social Sciences / Humans / Indocyanine Green / Laparoscopy / Laparoscopy - methods / Lymph Node Excision - methods / Lymph nodes / Lymph Nodes - diagnostic imaging / Lymph Nodes - pathology / Lymph Nodes - surgery / Lymphatic system / Medical imaging / Metastases / multidisciplinary / Optical Imaging - methods / Patients / Science / Science (multidisciplinary) / Stomach Neoplasms - diagnostic imaging / Stomach Neoplasms - pathology / Stomach Neoplasms - surgery / Survival