Indocyanine Green Fluorescence-Guided Lymphadenectomy in Laparoscopic Radical Gastrectomy for Gastric Cancer: A Pilot Randomized Pilot Study.

UNLABELLED: Adequate lymphadenectomy is crucial for optimal oncological outcomes in gastric cancer. Indocyanine green (ICG) fluorescence imaging may enhance lymph node retrieval during laparoscopic D2 lymphadenectomy. This study evaluates efficacy of ICG-guided lymphadenectomy in improving nodal yield and perioperative safety in gastric carcinoma. In this prospective randomized pilot study at a tertiary cancer care, 30 patients with gastric adenocarcinoma were randomized 1:1 to ICG-guided or standard laparoscopic D2 lymphadenectomy. ICG (0.5 mL, 2.5 mg/mL) was injected subserosally in the ICG group. The primary endpoint was total nodal yield; secondary endpoints included metastatic node ratio, morbidity, mortality, and operative outcomes. The ICG group had a significantly higher mean nodal yield (55.5 ± 14.3 vs. 41.2 ± 16.0 nodes, P = 0.0057). Metastatic node ratio (0.19 vs. 0.20) and positive nodes (10.7 vs. 8.3, P = 0.49) were similar. ICG group had increased D1 nodal yield (41.0 ± 14.5 vs. 25.3 ± 12.5, P = 0.006) but not D2 nodes (14.5 ± 5.3 vs. 15.9 ± 8.7, P = 0.51). Postoperative complications were similar, with Clavien-Dindo grade ≥ 2 occurring in 26.7% of patients in the ICG group versus 33.3% in the non-ICG group (P = 1), and no mortality was observed. Operative time, blood loss, and length of hospital stay were comparable between the groups. In this single-center pilot randomized study, ICG-guided lymphadenectomy during laparoscopic gastrectomy for gastric cancer resulted in a higher overall lymph node yield without affecting the metastatic nodal ratio. Larger trials are warranted to confirm these findings and evaluate long-term oncological benefits. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13193-025-02494-3.