Efficacy of ICG fluorescence-guided inguinal lymphadenectomy for penile cancer: a randomized trial.

Abstract

OBJECTIVES:

To investigate the safety and efficacy of indocyanine green (ICG) fluorescence-guided inguinal lymphadenectomy in patients with penile cancer.

PATIENTS AND METHODS:

A prospective, single-blind, randomized controlled clinical trial (ChiCTR2100044584) was performed among patients with penile caner who underwent bilateral modified inguinal lymphadenectomy at four centers in China between April 1, 2021, and June 30, 2022. Patients aged 18-80 years and diagnosed with squamous cell carcinomas were included. Each enrolled patient was randomly assigned either ICG fluorescence-guided inguinal lymphadenectomy by a laparoscopic or robotic-assisted approach in one groin, or with non-ICG fluorescence-guided inguinal lymphadenectomy in the other groin acting as a control. The primary outcome was the number of retrieved inguinal lymph nodes. Secondary outcomes included complications according to Clavien-Dindo classification and the lymph node noncompliance rate.

RESULTS:

Forty-five patients were included in the intention-to-treat analysis, and 42 of them who completed the entire study were included in the per-protocol analysis. No ICG-related complications occurred in any of the patients. The results of the intention-to-treat and per-protocol analyses indicated that the total number of unilateral inguinal lymph nodes retrieved were higher in the ICG side than in the non-ICG side (mean, 13 vs 9, difference 4 (95% CI 2.7-4.4), P =0.007), and the number of unilateral inguinal deep and superficial lymph nodes were higher in the ICG side. Furthermore, the lymph node noncompliance rate was lower in the ICG side than in the non-ICG side. Additionally, there was no significant difference in local complications in the groins between the two sides (P > 0.05).

CONCLUSION:

ICG fluorescence-guided inguinal lymphadenectomy was safe for patients with penile cancer. This procedure can improve the number of inguinal lymph nodes retrieved and reduce lymph node noncompliance without increased complications. ICG fluorescence-guided inguinal lymphadenectomy is beneficial and recommended for selected patients with penile cancer.

• Authors: Peng Yuan, Yu Xie, Ran Xu, Yuanwei Li, Kun Yao, Jianye Liu, Bin Yan, Shusuan Jiang, Qiang Lu, Qian Chen, Hongjing Zang, Wei Xiong, Yongxiang Tang, Shuo Hu, Long Wang
• Journal: BJU international (BJU Int) (Nov 20 2023) ISSN: 1464-410X [Electronic] England
• PMID: 37983593 (Publication Type: Journal Article)
• Copyright: This article is protected by copyright. All rights reserved.