Alhusseinawi Hayder, Nadler Naomi, Andersen Helene Reif, Vásquez Juan Luis, Norus Thomas, Azawi Nessn
Department of Clinical Medicine Aalborg University Hospital Aalborg Denmark.
Department of Urology Gødstrup Hospital Gødstrup Denmark.
BJUI Compass. 2025 Feb 19;6(2):e502. doi: 10.1002/bco2.502. eCollection 2025 Feb.
To investigate the feasibility, oncological efficacy and safety of robotic segmental ureterectomy (SU) for treating patients with localised upper tract urothelial carcinoma (UTUC). A key aspect of this research involves utilising Black Eye™ Endoscopic Marker Ink to delineate the boundary of the tumour in the ureter, helping to ensure precise surgical intervention and reducing the risk of positive surgical margin.
In a prospective non-randomised trial from January 2018 to December 2022, patients with localised UTUC confirmed by CT-urography were enrolled. A Multidisciplinary Team assessed patients for suitability for kidney-sparing surgery (KSS) with SU, marked by endoscopic Black Eye™ Endoscopic Marker Ink. Black Eye Endoscopic Marker Ink marking aimed to enhance surgical precision by delineating clear resection margins. The primary endpoints were the feasibility of the technique, local and bladder recurrence rates and surgical outcomes. Propensity score matching was used for a balanced comparison to the standard treatment Radical Nephroureterectomy (RNU).
Thirty patients underwent SU, in the period of study with only one local recurrence reported with a median follow-up time of 35 months. SU was associated with a significantly shorter operative time (41 minutes less on average, < 0.001) than RNU. Tumour size was significantly larger in the RNU group (median size 42.5 mm, IQR: 30-60.5) compared to the SU group (median size 30 mm, IQR: 20-35) ( = 0.007), potentially indicating selection bias towards RNU for more advanced cases. No significant difference between the groups was found in the post-operative Clavien-Dindo complication score nor in oncological outcomes.
SU with Black Eye™ Endoscopic Marker Ink marking is a viable KSS technique that offers a safe and effective alternative to RNU for patients with a single tumour, no longer than 30 mm and of low grade. This novel approach is promising in lowering the risk of positive margins, ensuring cancer control and preserving renal function.
探讨机器人输尿管节段切除术（SU）治疗局限性上尿路尿路上皮癌（UTUC）患者的可行性、肿瘤学疗效及安全性。本研究的一个关键方面是利用Black Eye™内镜标记墨水勾勒输尿管内肿瘤的边界，有助于确保精确的手术干预并降低手术切缘阳性的风险。
在2018年1月至2022年12月的一项前瞻性非随机试验中，纳入经CT尿路造影确诊的局限性UTUC患者。多学科团队评估患者是否适合采用SU进行保肾手术（KSS），并用内镜Black Eye™内镜标记墨水进行标记。Black Eye内镜标记墨水标记旨在通过勾勒清晰的切除边缘来提高手术精度。主要终点是该技术的可行性、局部和膀胱复发率以及手术结果。采用倾向评分匹配法与标准治疗根治性肾输尿管切除术（RNU）进行均衡比较。
30例患者接受了SU，在研究期间仅报告1例局部复发，中位随访时间为35个月。与RNU相比，SU的手术时间显著缩短（平均少41分钟，<0.001）。RNU组的肿瘤大小明显大于SU组（中位大小42.5mm，四分位间距：30 - 60.5）（中位大小30mm，四分位间距：20 - 35）（P = 0.007），这可能表明对于病情更严重的病例，RNU存在选择偏倚。两组在术后Clavien - Dindo并发症评分及肿瘤学结果方面均未发现显著差异。
采用Black Eye™内镜标记墨水标记的SU是一种可行的KSS技术，对于单个肿瘤、长度不超过30mm且低分级的患者，是RNU的安全有效替代方案。这种新方法有望降低切缘阳性的风险，确保癌症得到控制并保留肾功能。
