Comparison of Indocyanine Green-Guided Fluorescence with Fluorescein Sodium-Based Sentinel Lymph Node Biopsy in Patients with Breast Cancer: A Randomized Controlled Trial

Abstract

Sentinel lymph node biopsy (SLNB) is now the standard for axillary staging in early breast cancer, replacing axillary lymph node dissection due to lower morbidity while preserving diagnostic accuracy. Dual tracer methods using radioisotopes and blue dyes provide high detection rates but are often limited in resource-constrained settings. Indocyanine green (ICG) and fluorescein sodium have emerged as cost-effective alternatives. This study compared the efficacy, operative efficiency, and cost-effectiveness of ICG versus fluorescein sodium as single-dye tracers for SLNB.

Materials and Method

This study was conducted at AIIMS, New Delhi, between April 2020 and November 2021. Twenty female patients with early breast cancer and clinically node-negative axillae were randomized into two groups: Group A (ICG) and Group B (fluorescein sodium). Standard protocols for dye administration, visualization, and sentinel node dissection were followed. Histopathological analysis was performed for all excised nodes. Data were analyzed using Chi-square, Fisher’s exact, and Mann–Whitney U tests.

Result

Sentinel lymph nodes were identified in all patients with ICG (100%) and in 80% with fluorescein (p=0.47). The mean number of nodes retrieved was similar across groups. Operative time was significantly shorter in the ICG group (24.2 ± 2.56 min) compared with fluorescein (33 ± 4.93 min; p=0.001). However, the mean procedural cost was higher with ICG (INR 14,684.7) versus fluorescein (INR 908.9).

Conclusion

ICG showed higher identification rates and shorter operative time but at greater cost. With affordable near-infrared systems, ICG could serve as a reliable tracer alternative in resource-limited settings.