■淋巴结转移是阴茎癌(PeCa)的主要生存和预后因素。因此,准确分期,预后,和治疗选择需要足够的腹股沟淋巴结清扫术(ILND)。ILND手术应平衡肿瘤的严密性与发病率和术后并发症。我们的目的是比较开放式ILND(OILND)和视频内窥镜ILND(VEILND)在PeCa患者中的可行性和安全性。
■我们在2019年10月至2023年4月之间进行了一项单中心随机试验,采用患者内设计。纳入接受PECA分期或根治性ILND的患者,并随机接受一侧的OILND或VEILND,然后在对侧使用另一种技术。该试验得到当地伦理委员会的批准,并在ClinicalTrials.gov(NCT05887921)上注册。主要结果是VEILND的安全性。次要结果包括两种手术的术中和术后发病率和手术结果,以及根据生存估计的肿瘤学结果。
■我们纳入了14名患者的研究。中位随访时间为12个月(四分位距[IQR]12-17)。OILND和VEILND在手术时间和淋巴结清除数上没有显着差异。然而,VEILND组排水去除的中位时间显著缩短(15d,IQR13-17,95%置信区间[CI]12-17)比OILND组(27d,IQR20-41,95%CI24-31;p=0.025)。术中无并发症,但术后并发症3例(21.4%,95%CI8.4-37.8%)在VEILND组和八个(57.1%,油组的95%CI18.6-54.3%)(p=0.032)。
■VEILND代表了一种安全的技术,可以考虑对PeCa进行分期或治愈,并且在发病率方面似乎比OILND具有优势。需要进一步的高能研究来证实这些初步结果。
■我们比较了两种不同的手术技术切除阴茎癌患者淋巴结的结果。我们发现,视频辅助的锁孔手术方法似乎比开放手术后的并发症发生率更低。
UNASSIGNED: Nodal metastasis is a major survival and prognostic factor in penile cancer (PeCa). Thus, accurate staging, prognosis, and treatment selection require adequate inguinal lymphadenectomy (ILND). ILND surgery should balance oncologic rigor with morbidity and postoperative complications. Our aim was to compare the feasibility and safety of open ILND (OILND) and videoendoscopic ILND (VEILND) in patients with PeCa.
UNASSIGNED: We conducted a single-center randomized
trial with a within-patient design between October 2019 and April 2023. Patients who were undergoing either staging or radical ILND for PeCa were included and randomized to receive either OILND or VEILND on one side, with the other technique then used on the contralateral side. The
trial was approved by the local ethics committee and was registered on ClinicalTrials.gov (NCT05887921). The primary outcome was the safety of VEILND. Secondary outcomes included intraoperative and postoperative morbidity rates and surgical outcomes for the two procedures, as well as oncological outcomes according to survival estimates.
UNASSIGNED: We included 14 patients in the
study. Median follow-up was 12 mo (interquartile range [IQR] 12-17). There were no significant differences in operative time and the number of lymph nodes removed between OILND and VEILND. However, the median time to drain removal was significantly shorter in the VEILND group (15 d, IQR 13-17, 95% confidence interval [CI] 12-17) than in the OILND group (27 d, IQR 20-41, 95% CI 24-31; p = 0.025). No intraoperative complications were observed, but postoperative complications occurred in three cases (21.4%, 95% CI 8.4-37.8%) in the VEILND group and eight (57.1%, 95% CI 18.6-54.3%) in the OILND group (p = 0.032).
UNASSIGNED: VEILND represents a safe technique to consider for either staging or curative intent in PeCa and seems to have an advantage over OILND in terms of morbidity. Further high-powered studies are warranted to confirm these preliminary results.
UNASSIGNED: We compared the outcomes of two different surgical techniques to remove lymph nodes in patients with penile cancer. We found that a video-assisted keyhole surgery approach seems to result in a lower rate of complications than after open surgery.