ObjectivesTo determine the safety and oncological advantages of en bloc resection of bladder tumour (ERBT) vs conventional transurethral resection of bladder tumour (cTURBT) in terms of resection quality, staging quality, and safety.Patients and MethodsWe conducted a single‐blinded randomised controlled trial at seven European hospitals with the following inclusion criteria: first diagnosis of non‐muscle‐invasive bladder cancer, no singular carcinoma in situ, and tumour size >4.3 mm. Patients were randomised intraoperatively in a 1:1 ratio to either the ERBT or cTURBT group. Outcome analysis was performed using the chi‐square test, t‐test, and multivariate regression analysis.ResultsA total of 97 patients were randomised into the study (cTURBT = 40, ERBT = 57). A switch to cTURBT was necessary in two patients (3.5%) and 11.5% of the screened patients were preoperatively excluded for ERBT. There was no difference in the specimen presence of detrusor muscle with 73.7% in cTURBT and 67.3% in ERBT specimens (P = 0.69). There were no significant differences in mean operative time (ERBT 27.6 vs cTURBT 25.4 min, P = 0.450) or mean resection time (ERBT 16.3 vs cTURBT 15.5 min, P = 0.732). Overall the complication rate did not differ significantly (ERBT 18.2% vs cTURBT 7.5%, P = 0.142). Bladder perforations occurred significantly more often in the ERBT group (ERBT seven vs cTURBT none, P = 0.020). R0 status was reported more often after ERBT, whilst a second resection was significantly less frequent after ERBT (P = 0.018). Recurrence rates were comparable for both techniques after 6 months of follow‐up.ConclusionThe feasibility of ERBT is higher than previously reported. Whereas other perioperative and safety parameters are comparable to cTURBT, bladder perforations occurred significantly more often in the ERBT group and raised safety concerns. This is why this trial was terminated.

中文翻译：

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膀胱肿瘤整块切除术与常规经尿道膀胱肿瘤切除术的国际多中心随机对照试验：膀胱尿路上皮癌整块切除术 （EBRUC） II 试验的初步结果


目的确定膀胱肿瘤整块切除术 （ERBT） 与常规经尿道膀胱肿瘤切除术 （cTURBT） 在切除质量、分期质量和安全性方面的安全性和肿瘤学优势。患者和方法我们在 7 家欧洲医院进行了一项单盲随机对照试验，纳入标准如下： 首次诊断为非肌层浸润性膀胱癌，无单一原位癌，肿瘤大小 >4.3 mm。患者在术中以 1：1 的比例随机分配到 ERBT 或 cTURBT 组。使用卡方检验、 t 检验和多变量回归分析进行结果分析。结果共有 97 例患者被随机分配到研究中 （cTURBT = 40，ERBT = 57）。2 例患者 （3.5%） 需要改用 cTURBT，11.5% 的筛查患者术前被排除在 ERBT 之外。逼尿肌的标本存在没有差异，cTURBT 为 73.7%，ERBT 标本为 67.3% （P = 0.69）。平均手术时间 （ERBT 27.6 vs cTURBT 25.4 min，P = 0.450） 或平均切除时间 （ERBT 16.3 vs cTURBT 15.5 min，P = 0.732） 无显著差异。总体而言，并发症发生率无显著差异 （ERBT 18.2% vs cTURBT 7.5%，P = 0.142）。ERBT 组膀胱穿孔的发生率显著更高 （ERBT 7 vs cTURBT 无，P = 0.020）。ERBT 后 R0 状态报告率更高，而 ERBT 后第二次切除的频率显著降低 （P = 0.018）。随访 6 个月后，两种技术的复发率相当。结论ERBT 的可行性高于既往报道。 虽然其他围手术期和安全参数与 cTURBT 相当，但 ERBT 组膀胱穿孔的发生率明显更高，并引发了安全问题。这就是终止此试验的原因。