Indocyanine green fluorescence in pelvic lymph node dissection during laparoscopic radical prostatectomy: a randomized controlled trial

To evaluate the feasibility and diagnostic accuracy of indocyanine green (ICG)-guided pelvic lymph node dissection (PLND) during laparoscopic radical prostatectomy, and compare the lymph node detection rate and 3-year biochemical recurrence (BCR) rate between PLND and ICG-guided PLND. Sixty-eight patients were randomly divided into intervention and control groups (1:1). The intervention group underwent standard pelvic lymph node dissection (sPLND) and fluorescent visible sentinel lymph node dissection (SLND) after an ultrasound-guided injection of ICG (25 mg), while the control group received sPLND without ICG injection. Kaplan-Meier survival curves were used to compare the two groups of patients for BCR at a point three years post-surgery. In the intervention group, 284 lymph nodes were removed, and 58 lymph nodes were visualized by ICG, including 4 positive lymph nodes. In the control group, 205 lymph nodes were removed. There were three cases of ICG leakage and six cases of lymphocele in the intervention group and one case of lymphocele in the control group. The sensitivity and specificity of ICG-guided lymph node dissection was 80.00% and 82.29%, respectively, while the area under the curve (AUC) of the receiver operating characteristic (ROC) curve was 0.727. The patients in the intervention group had longer biochemical recurrence-free survival (BRFS) rates compared to those in the control group. ICG-mediated fluorescence imaging technology is safe and reliable, although the sensitivity and specificity of identifying metastatic lymph nodes was not sufficient. This technique can be used as an auxiliary method to optimize BRFS, increase diagnostic accuracy during lymph node dissection, and reduce misdiagnosis.