Department of Urology, The Third Xiangya Hospital, Central South University, Changsha, China.
Department of Urology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.
BJU Int. 2024 Apr;133(4):442-450. doi: 10.1111/bju.16231. Epub 2023 Dec 13.
To investigate the safety and efficacy of indocyanine green (ICG) fluorescence-guided inguinal lymph node dissection (ILND) in patients with penile cancer.
A prospective, single-blind, randomised controlled clinical trial (ChiCTR2100044584) was performed among patients with penile caner who underwent bilateral modified ILND at four centres in China between 1 April 2021 and 30 June 2022. Patients aged 18-80 years and diagnosed with squamous cell carcinomas were included. Each enrolled patient was randomly assigned to either ICG fluorescence-guided ILND by a laparoscopic or robot-assisted approach in one groin, with non-ICG fluorescence-guided ILND in the other groin acting as a control. The primary outcome was the number of retrieved ILNs. Secondary outcomes included complications according to the Clavien-Dindo classification and the ILN non-compliance (inadequate removal of ILNs) rate.
A total of 45 patients were included in the intention-to-treat (ITT) analysis, and the 42 who completed the entire study were included in the per protocol (PP) analysis. There were no ICG-related complications in any of the patients. The results of the ITT and PP analyses indicated that the total number of unilateral ILNs retrieved was higher on the ICG side than on the non-ICG side (mean 13 vs 9 ILNs, difference 4 ILNs [95% CI 2.7-4.4], P = 0.007), and the number of unilateral deep and superficial ILNs was higher on the ICG side. Furthermore, the LN non-compliance rate was lower on the ICG side than on the non-ICG side. Additionally, there was no significant difference in local complications in the groins between the two sides (P > 0.05).
An ICG fluorescence-guided ILND was safe for patients with penile cancer. This procedure can improve the number of ILNs retrieved and reduce the LN non-compliance rate without increased complications. ICG fluorescence-guided ILND is beneficial and recommended for selected patients with penile cancer.
研究吲哚菁绿（ICG）荧光引导腹股沟淋巴结清扫术（ILND）在阴茎癌患者中的安全性和有效性。
这是一项在中国四家中心进行的前瞻性、单盲、随机对照临床试验（ChiCTR2100044584）。纳入 2021 年 4 月 1 日至 2022 年 6 月 30 日期间接受双侧改良 ILND 的阴茎癌患者，年龄 18-80 岁，诊断为鳞状细胞癌。每位入组患者随机分配至腹腔镜或机器人辅助的一侧腹股沟 ICG 荧光引导 ILND，另一侧腹股沟行非 ICG 荧光引导 ILND 作为对照。主要结局为检出的 ILN 数量。次要结局包括根据 Clavien-Dindo 分类的并发症发生率和 ILN 不合格（ILN 切除不充分）率。
共有 45 例患者纳入意向治疗（ITT）分析，42 例完成整个研究的患者纳入符合方案（PP）分析。所有患者均无 ICG 相关并发症。ITT 和 PP 分析结果表明，ICG 侧单侧 ILN 检出总数高于非 ICG 侧（平均 13 比 9 个 ILN，差异 4 个 ILN[95%CI 2.7-4.4]，P=0.007），单侧深、浅 ILN 数量也更高。此外，ICG 侧的 LN 不合格率低于非 ICG 侧。此外，两侧腹股沟局部并发症发生率无显著差异（P>0.05）。
ICG 荧光引导 ILND 对阴茎癌患者是安全的。该方法可以提高 ILN 检出数量，降低 LN 不合格率，且不增加并发症。对于选择的阴茎癌患者，ICG 荧光引导 ILND 是有益的，值得推荐。
