Department of Urology, Fundació Puigvert, Autonomous University of Barcelona, Barcelona, Spain.
Department of Urology, Fundació Puigvert, Autonomous University of Barcelona, Barcelona, Spain; Department of Urology, Humanitas Research Hospital IRCCS, Rozzano, Italy.
Eur Urol Oncol. 2022 Aug;5(4):440-448. doi: 10.1016/j.euo.2022.05.001. Epub 2022 May 23.
It has been proposed that en bloc resection of bladder tumor (ERBT) improves the quality of tumor resection. A recent international collaborative consensus statement on ERBT underlined the lack of high-quality prospective studies precluding the achievement of solid conclusion on ERBT.
To compare conventional transurethral resection of bladder tumor (cTURBT) and ERBT.
DESIGN, SETTING, AND PARTICIPANTS: This study (NCT04712201) was a prospective, randomized, noninferiority trial enrolling patients diagnosed with bladder cancer (BC) undergoing endoscopic intervention. Inclusion criteria were: tumor size ≤3 cm, three or fewer lesions, and no sign of muscle invasion and/or ureteral involvement. For a noninferiority rate in BC staging of 5% (α risk 2.5%; β risk 20%), a total of 300 subjects were randomized to ERBT treatment at a 1:1.5 allocation ratio.
TURBT and ERBT.
The primary outcome was the presence of detrusor muscle at final histology. Secondary outcomes include BC staging, T1 substaging, artifacts, complications, the rate of adjuvant treatment, and oncological outcomes.
From April 2018 to June 2021, 300 patients met the inclusion criteria. Of these, 248 (83%) underwent the assigned intervention: 108 patients (44%) underwent cTURBT and 140 (57%) underwent ERBT. The rate of detrusor muscle presence for ERBT was noninferior to that for TURBT (94% vs 95%; p = 0.8). T1 substaging was feasible in 80% of cTURBT cases versus 100% of ERBT cases (p = 0.02). Complication rates, rates of postoperative adjuvant treatment, catheterization time, and hospital stay were comparable between the two groups (p > 0.05). The recurrence rate at median follow-up of 15 mo (interquartile range 7-28) was 18% for cTURBT versus 13% for ERBT (p = 0.16). Limitations include the single high-volume institution and the short-term follow-up.
Our study has the highest level of evidence for comparison of ERBT versus TURBT. ERBT was noninferior to TURBT for BC staging. The rate of T1 substaging feasibility was significantly higher with ERBT.
We compared two techniques for removing tumors from the bladder. The en bloc technique removes the tumor in one piece and is not inferior to the conventional method in terms of the quality of the surgical resection and cancer staging assessment.
有研究提出整块切除膀胱肿瘤（ERBT）可提高肿瘤切除质量。最近的一项国际协作共识声明强调，缺乏高质量的前瞻性研究，无法得出关于 ERBT 的确定性结论。
比较经尿道膀胱肿瘤切除术（cTURBT）和 ERBT。
设计、地点和参与者：这是一项前瞻性、随机、非劣效性试验，纳入诊断为膀胱癌（BC）并接受内镜治疗的患者。纳入标准为：肿瘤大小≤3cm，病变≤3 个，无肌肉侵犯和/或输尿管受累的迹象。BC 分期的非劣效性率为 5%（α风险 2.5%；β风险 20%），共 300 例患者按 1:1.5 的比例随机分配至 ERBT 治疗。
TURBT 和 ERBT。
主要结局为最终病理检查存在逼尿肌。次要结局包括 BC 分期、T1 亚分期、伪影、并发症、辅助治疗率和肿瘤学结局。
2018 年 4 月至 2021 年 6 月，300 例患者符合纳入标准。其中 248 例（83%）接受了指定的干预措施：108 例（44%）行 cTURBT，140 例（57%）行 ERBT。ERBT 的逼尿肌存在率不劣于 TURBT（94%比 95%；p=0.8）。cTURBT 的 T1 亚分期可行率为 80%，ERBT 为 100%（p=0.02）。两组并发症发生率、术后辅助治疗率、导尿管留置时间和住院时间无显著差异（p>0.05）。中位随访 15 个月（四分位间距 7-28）时，cTURBT 的复发率为 18%，ERBT 为 13%（p=0.16）。局限性包括单一的高容量机构和短期随访。
本研究为 ERBT 与 TURBT 比较提供了最高级别的证据。ERBT 在 BC 分期方面不劣于 TURBT。ERBT 的 T1 亚分期可行性显著更高。
我们比较了两种从膀胱中切除肿瘤的技术。整块切除技术将肿瘤整块切除，在手术切除质量和癌症分期评估方面与传统方法无差异。
