Fluorescence-supported lymphography and extended pelvic lymph node dissection in robot-assisted radical prostatectomy: a prospective, randomized trial
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To demonstrate the benefits of fluorescence-supported extended pelvic lymph node dissection (ePLND) compared to regular ePLND in robot-assisted radical prostatectomy.
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.
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.
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.
KeywordsRobot-assisted radical prostatectomy Fluorescence Sentinel lymph node Pelvic lymph node dissection Indocyanine green
NH Protocol/project development, data collection and management, data analysis, manuscript writing; MG Protocol/project development, data collection and management; CW Data collection and management, manuscript editing; MA Data collection and management; BF Data collection and management; KU Data collection and management, manuscript editing; BH Manuscript editing; JHW Protocol/project development, data collection and management, manuscript editing
Compliance with ethical standards
All procedures in this study involving human participants were in accordance with the ethical standards of the institutional committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.Informed consent was obtained from all individual participants included in the study.
Conflicts of interest
The authors declare that they have no conflict of interest.
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