由于初次切除后存在分期不足和/或疾病持续存在的风险，欧洲泌尿外科协会 (EAU) 关于非肌层浸润性膀胱癌 (NMIBC) 的指南建议进行第二次经尿道膀胱肿瘤切除术 (Re-TURBT)。然而，在许多情况下，这可能是不必要的、潜在有害的，并且成本高昂，构成过度治疗。无 CUT 试验旨在将膀胱成像报告和数据系统 (VI-RADS) 的术前分期准确性与光动力诊断 (PDD) 的术中增强能力相结合，以克服主要的 TURBT 缺陷，从而有可能重新定义 Re 的标准-TURBT 适应症。单中心、非劣效性、IV 期、开放标签、随机对照试验，比例为 1:1。主要终点是研究组之间的短期 BC 复发，以评估患者术前是否归类为 VI- RADS 评分 1 和/或评分 2（即 MIBC 的可能性极低和极低）可以通过进行初次 PDD-TURBT 安全地避免 Re-TURBT。次要终点包括中长期 BC 复发和进展 (i-ii)。此外，还将进行与健康相关的生活质量 (HRQoL) 结果 (iii) 和健康经济成本效益分析 (iv)。所有患者都将接受术前膀胱多参数磁共振成像，并确定 VI-RADS 评分。根据 EAU 指南，共有 327 名患有中/高风险 NMIBC 的候选患者接受 Re-TURBT，为期 3 年。参与者将被随机（1:1 比例）接受任一标准护理 (SoC)，包括初次白光 (WL) TURBT，然后是第二次 WL Re-TURBT；或实验组，包括初次 PDD-TURBT 并省略 Re-TURBT。两组都将根据风险调整时间表接受辅助膀胱内治疗和监测。主要结果的衡量标准是 4.5 个月内 SoC 组和实验组之间 BC 复发的相对比例（即首次随访膀胱镜检查时检测到的任何“早期”复发）。次要结果指标是 4.5 个月随访后检测到的晚期 BC 复发和/或 BC 进展的相对比例。此外，我们将计算在患者一生范围内建模的 NMIBC 问卷的 HRQoL 变化以及健康经济分析，包括对每次 Re-TURBT 避免的增量成本的短期成本效益评估以及每个质量的长期成本效用-使用 2 年临床结果获得的调整生命年，以驱动两个治疗组的终生模型。ClinicalTrial.gov 标识符 (ID)：NCT05962541；欧盟药物监管机构临床试验数据库 (EudraCT) ID：2023-507307-64-00.© 2024 作者。 BJU International 约翰·威利 (John Wiley) 出版

A second transurethral resection of bladder tumour (Re-TURBT) is recommended by European Association of Urology (EAU) Guidelines on non-muscle-invasive bladder cancers (NMIBCs) due to the risk of understaging and/or persistent disease following the primary resection. However, in many cases this may be unnecessary, potentially harmful, and significantly expensive constituting overtreatment. The CUT-less trial aims to combine the preoperative staging accuracy of Vesical Imaging-Reporting and Data System (VI-RADS) and the intraoperative enhanced ability of photodynamic diagnosis (PDD) to overcome the primary TURBT pitfalls thus potentially re-defining criteria for Re-TURBT indications.Single-centre, non-inferiority, phase IV, open-label, randomised controlled trial with 1:1 ratio.The primary endpoint is short-term BC recurrence between the study arms to assess whether patients preoperatively categorised as VI-RADS Score 1 and/or Score 2 (i.e., very-low and low likelihood of MIBC) could safely avoid Re-TURBT by undergoing primary PDD-TURBT. Secondary endpoints include mid- and long-term BC recurrences and progression (i-ii). Also, health-related quality of life (HRQoL) outcomes (iii) and health-economic cost-benefit analysis (iv) will be performed.All patients will undergo preoperative Multiparametric Magnetic Resonance Imaging of the bladder with VI-RADS score determination. A total of 327 patients with intermediate-/high-risk NMIBCs, candidate for Re-TURBT according to EAU Guidelines, will be enrolled over a 3-year period. Participants will be randomised (1:1 ratio) to either standard of care (SoC), comprising primary white-light (WL) TURBT followed by second WL Re-TURBT; or the Experimental arm, comprising primary PDD-TURBT and omitting Re-TURBT. Both groups will receive adjuvant intravesical therapy and surveillance according to risk-adjusted schedules. Measure of the primary outcome will be the relative proportion of BC recurrences between the SoC and Experimental arms within 4.5 months (i.e., any 'early' recurrence detected at first follow-up cystoscopy). Secondary outcomes measures will be the relative proportion of late BC recurrences and/or BC progression detected after 4.5 months follow-up. Additionally, we will compute the HRQoL variation from NMIBC questionnaires modelled over a patient lifetime horizon and the health-economic analyses including a short-term cost-benefit assessment of incremental costs per Re-TURBT avoided and a longer-term cost-utility per quality-adjusted life year gained using 2-year clinical outcomes to drive a lifetime model across the two arms of treatment.ClinicalTrial.gov identifier (ID): NCT05962541; European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) ID: 2023-507307-64-00.© 2024 The Author(s). BJU International published by John Wiley & Sons Ltd on behalf of BJU International.