Clinical implications of Indocyanine Green Fluorescence Imaging-Guided laparoscopic lymphadenectomy for patients with gastric cancer: A cohort study from two randomized, controlled trials using individual patient data.

BACKGROUND: The value of indocyanine green (ICG) fluorescence imaging in tracing metastatic lymph nodes (LNs) has rarely been reported. We aimed to evaluate the clinical implications of fluorescence imaging-guided lymphadenectomy and the sensitivity of fluorescent lymphography to detect metastatic LN stations in gastric cancer (GC). MATERIALS AND METHODS: This analysis pooled data from two randomized controlled trials (FUGES-012 and FUGES-019 studies) on laparoscopic ICG tracer-guided lymphadenectomy for GC between November 2018 and October 2020. Patients who received ICG injection using either the intraoperative subserosal or preoperative submucosal approaches 1 day before surgery and underwent fluorescence imaging-guided lymphadenectomy were defined as the ICG group. Patients who underwent conventional lymphadenectomy without ICG injection and intraoperative imaging were defined as the non-ICG group. RESULTS: Among 514 enrolled patients, the ICG and non-ICG groups included 385 and 129, respectively. A significantly higher mean number of LNs was retrieved in the ICG group than in the non-ICG group (49.9 vs. 42.0, P < 0.001). The ICG group showed a lower LN noncompliance rate than that in the non-ICG group (31.9% vs. 57.4%, P < 0.001). The sensitivity of fluorescence imaging for detecting all metastatic LN stations was 86.8%. The negative predictive value was 92.2% for nonfluorescent stations. For detecting all metastatic stations, subgroup analysis revealed 97.7%, 91.7%, 86.2%, and 84.3% sensitivities for pT1, pT2, pT3, and pT4a tumors, respectively. Regardless of gastrectomy type, the diagnostic accuracy for detecting all metastatic stations in the D1+ and D2 stations for cT1-cT2 disease reached 100%. CONCLUSION: ICG fluorescence imaging, using either the subserosal or submucosal approaches, assisted in the thorough dissection of potentially metastatic LNs, as recommended for individualized laparoscopic lymphadenectomy for GC.