Fluorescence-supported lymphography and extended pelvic lymph node dissection in robot-assisted radical prostatectomy: a prospective, randomized trial.

PURPOSE: To demonstrate the benefits of fluorescence-supported extended pelvic lymph node dissection (ePLND) compared to regular ePLND in robot-assisted radical prostatectomy.
METHODS: 120 patients with intermediate- or high-risk prostate cancer were prospectively randomized (1:1): in the intervention group, indocyanine green (ICG) was injected transrectally into the prostate before docking of the robot. In both groups, ePLND was performed including additional dissection of fluorescent lymph nodes (LN) in the ICG group.
RESULTS: After drop-out of two patients, 59 patients were allocated to the control (A) and intervention group (B) with a median PSA of 8,6 ng/ml. Median console time was 159 (A) vs. 168 (B) min (p = 0.20) with a longer time for ICG-ePLND: 43 (A) vs. 55 min (B) (p = 0.001). 2609 LN were found with significantly more LN after ICG-supported ePLND with a median of 25 vs. 17 LN in A (p < 0.001). Nodal metastases were detected in 6 patients in A (25 cancerous LN) vs. 9 patients in B (62 positive LN) (p = 0.40). In seven of nine patients, ICG-ePLND identified at least one cancer-positive LN (sensitivity 78%), 27 of 62 cancerous LN were fluorescent. Symptomatic lymphocele occurred in one patient in a and in three patients in b (p = 0.62). After a median follow-up of 22.9 months, PSA levels were similar.
CONCLUSIONS: While ICG-ePLND seems to be beneficial for a better understanding of the lymphatic drainage and a more meticulous diagnostic approach, the sensitivity is not sufficient to recommend stand-alone ICG lymph node dissection.

RCT Entities:   Population Interventions Outcomes