单次膀胱内滴注丝裂霉素C对输尿管镜下尿路上皮癌膀胱内复发率的影响：一项真诚的前瞻性多中心注册研究

IF 4.5 3区医学 Q1 UROLOGY & NEPHROLOGY

European Urology Open Science Pub Date : 2025-04-28 DOI:10.1016/j.euros.2025.03.017

Orlane Figaroa , Ranan Dasgupta , Nora Hendriks , Guido Kamphuis , Jorg Oddens , Jeroen van Moorselaar , Adriaan Bins , Joyce Baard

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引用次数: 0

摘要

上尿道尿路上皮癌（UTUC）是一种罕见的恶性肿瘤，占所有尿路上皮癌（UCs）的5-10%。根治性肾输尿管切除术（RNU）一直是标准的治疗方法，但通过输尿管镜（URS）进行保肾手术（KSS）现在被推荐用于低风险病例。KSS与较高的膀胱内复发率（IVR）相关。该研究旨在评估URS术后单次膀胱内滴注丝裂霉素C （SI-MMC）是否能降低IVR率。研究设计：这是一项前瞻性多中心注册研究，纳入了接受URS和SI-MMC治疗的非转移性UTUC患者。数据将与没有辅助MMC的历史对照队列进行比较。患者年龄≥18岁，无膀胱癌或对侧UTUC病史。这项研究遵循《赫尔辛基宣言》的原则，并已获得伦理批准。主要和次要结果主要结果是IVR总数和到IVR的时间。次要结果是评估内镜治疗后UTUC患者IVR的预测变量。考虑到URS后的高复发率，本研究的目的是提供关于使用MMC来减少IVR的证据，并解决目前缺乏可靠数据的问题。该研究通过证明SI-MMC在预防UTUC患者URS后IVR的有效性，有可能改变临床实践。

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Effect of a Single Intravesical Instillation of Mitomycin C on the Intravesical Recurrence Rate After Ureteroscopy for Upper Tract Urothelial Carcinoma: The SINCERE Prospective Multicenter Registry Study

Background

Upper tract urothelial carcinoma (UTUC) is a rare malignancy, accounting for 5–10% of all urothelial carcinomas (UCs). Radical nephroureterectomy (RNU) has been the standard treatment, but kidney-sparing surgery (KSS) via ureteroscopy (URS) is now recommended for low-risk cases. KSS is associated with a higher rate of intravesical recurrence (IVR). The SINCERE study is evaluating whether a single postoperative intravesical instillation of mitomycin C (SI-MMC) after URS can reduce the IVR rate.

Study design

This is a prospective multicenter registry study enrolling patients with nonmetastatic UTUC undergoing URS followed by SI-MMC. Data will be compared to a historical control cohort without adjuvant MMC. Patients are aged ≥18 yr with no history of bladder cancer or contralateral UTUC. The study is following the principles of the Declaration of Helsinki and has received ethics approval.

Primary and secondary outcomes

The primary outcome is total IVR and time to IVR. The secondary outcome is evaluation of predictive variables for IVR in patients with UTUC after endoscopic treatment.

Discussion

Given the high recurrence rate after URS, the study aim is to provide evidence regarding MMC use to reduce IVR and address the current lack of robust data for this strategy. The study has potential to change clinical practice by demonstrating the efficacy of SI-MMC in preventing IVR after URS for UTUC.

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