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

Abstract

Background Application 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. Method This 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. Results In 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). Conclusion ICG 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 registration ClinicalTrials.gov, NCT04219332.

The Use of Indocyanine Green (ICG) and Near-Infrared (NIR) Fluorescence-Guided Imaging in Gastric Cancer Surgery: A Narrative Review

“…Ultimately, the cost-effectiveness analysis performed in this study demonstrated how a subserosal injection can be a valid, cheaper solution, particularly considering the workload reduction experienced by endoscopists for tumors other than cT1. In conclusion, the authors did not find any difference in the lymph node-related outcomes between the two methods, with better patient satisfaction and cost effectiveness in favor of subserosal injection; however, they underlined how similar studies should be conducted by analyzing data from neoadjuvated patients ( 59 ).…”

“…In a cohort study, Zhong et al presented pooled data from the previously cited FUGES-012 trial ( 23 ) and FUGES-019 trial ( 59 ). The authors confirmed a higher number of retrieved lymph nodes and a reduction in the non-compliance rate of D2 lymphadenectomies performed using ICG.…”

Fluorescence-guided laparoscopic lymph node biopsy in a lymphoma patient: a possible new clinical application of indocyanine green

“…In colo-rectal or gastric cancer, after the peritumoral injection of ICG, the dye follows the lymphatic pathways and colors the lymph nodes it finds along the collectors. The presence of cancer cells within the metastatic lymph node does not seem to decrease the intensity of staining [ 10 ].…”

Intraoperative fluorescence molecular imaging accelerates the coming of precision surgery in China

“…3c ). The same surgical team further compared the performance of sub-mucosal and sub-serosal injection of ICG [ 74 ]. A total of 259 patients were enrolled in this per-protocol analysis.…”