• Bmc Med · Oct 2021

    Randomized Controlled Trial

    Comparison of submucosal and subserosal approaches toward optimized indocyanine green tracer-guided laparoscopic lymphadenectomy for patients with gastric cancer (FUGES-019): a randomized controlled trial.

    • Qi-Yue Chen, Qing Zhong, Ping Li, Jian-Wei Xie, Zhi-Yu Liu, Xiao-Bo Huang, Guang-Tan Lin, Jia-Bin Wang, Jian-Xian Lin, Jun Lu, Long-Long Cao, Mi Lin, Qiao-Ling Zheng, Ru-Hong Tu, Ze-Ning Huang, Chao-Hui Zheng, and Chang-Ming Huang.
    • Department of Gastric Surgery, Fujian Medical University Union Hospital, No. 29 Xinquan Rd, Fuzhou, 350001, China.
    • Bmc Med. 2021 Oct 27; 19 (1): 276.

    BackgroundApplication of indocyanine green (ICG) fluorescence imaging is effective in guiding laparoscopic radical lymphadenectomy for gastric cancer. However, the optimal approach for indocyanine green injection is controversial. Therefore, the objective of this study was aimed to compare the efficacy and ICG injection between the preoperative submucosal and intraoperative subserosal approaches for lymph node (LN) tracing during laparoscopic gastrectomy.MethodThis randomized controlled trial (ClinicalTrials.gov, NCT04219332) included 266 patients with potentially resectable gastric cancer (cT1-T4a, N0/+, M0) enrolled from a tertiary teaching center between December 2019 and October 2020. The primary endpoint was total number of retrieved LNs.ResultsIn total, 259 patients (n = 130 and n = 129 in the submucosal and subserosal groups, respectively) were included in the per-protocol analysis. There are no significant differences in total number of retrieved LNs between the two groups (49.8 vs. 49.2, P = 0.713). The rate of LN noncompliance in the submucosal group was comparable to that in the subserosal group (32.3% vs. 33.3%, P = 0.860). No significant difference was found between the submucosal and subserosal groups in terms of the incidence (17.7% vs. 16.3%; P = 0.762) or severity of postoperative complications. The mean fluorescence cost in the submucosal group was higher than that in the subserosal group ($335.3 vs. $182.4; P < 0.001). The overall treatment satisfaction score was lower in the submucosal group than in the subserosal group (70.5 vs. 76.1%, P = 0.048).ConclusionICG administered by subserosal injection was comparable to that administered by submucosal injection for lymph node tracing in gastric cancer. However, the former approach imposed a lower economic and mental burden on patients undergoing laparoscopic D2 lymphadenectomy.Trial RegistrationClinicalTrials.gov, NCT04219332 .© 2021. The Author(s).

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