背景:与常规TURB(cTURB)相比,经尿道膀胱整体切除术(eTURB)可以改善非肌层浸润性膀胱癌(NMIBC)的手术治疗。
目的:评估eTURB在NMIBC的切除和标本检索中是否优于cTURB。
方法:这是一个随机的,多中心试验在3个大小为1-3厘米的cTa-T1NMIBC肿瘤患者中,他们从2019年1月到2022年1月注册。
方法:参与者以1:1的比例随机接受eTURB(n=192)或cTURB(n=192)。
方法:主要结果是检索到的样本中逼尿肌(DM)的患病率。次要终点包括膀胱穿孔,持续性疾病在第二次看TURB,侧切缘阳性,正深切缘,操作时间,穿孔率,闭孔反射,从eTURB转换为cTURB,无复发生存率,3个月时疾病复发。
结论:共384例患者随机接受eTURB或cTURB。总共切除了452个肿瘤,并分析了主要结果。eTURB在DM的检索中优于cTURB(80.7%vs71.1%;混合模型p=0.01)。膀胱穿孔(5.6%vs12%;差异-6.4%;95%置信区间[CI]-12.2%至-0.6%)和闭孔反射(8.4%vs16%;差异-7.6%;95%CI-14.3%至-0.9%)在eTURB臂中的频率低于cTURB臂。两种技术的手术时间没有差异(26分钟,eTURB与25分钟的四分位数间距[IQR]20-38,cTURB的IQR17-35;差异1分钟,95%CI-25.9~4.99)。在eTURB臂的24例患者和cTURB臂的34例患者中进行了第二次TURB,乳头状病残留率无差异(pTa/pT1:56%vs55.9%;差异0.1%,95%CI-25.5%至25.7%)。在中位随访13个月(IQR7-20)时,eTURB组中18.4%的患者和cTURB组中16.7%的患者经历过膀胱癌复发(Cox风险比0.87,95%CI0.49-1.52;p=0.6)。
结论:在临床上患有NMIBC的患者中,肿瘤的大小为1-3厘米,与cTURB相比,通过eTURB切除肿瘤导致病理标本中DM的发生率更高.此外,eTURB与cTURB相比,闭孔反射和膀胱穿孔的频率较低。在改进NMIBC质量指标的同时,eTURB的长期差异肿瘤学获益仍不确定.
结果:我们比较了两种切除膀胱肿瘤的技术,发现肿瘤切除在一块,叫做整块切除术,与传统方法相比,为病理分析提供了质量更好的标本,并发症更少。该试验在ClinicalTrials.gov注册为NCT03718754。
BACKGROUND: En bloc transurethral resection of the bladder (eTURB) might improve the surgical management of non-muscle-invasive bladder cancer (NMIBC) in comparison to conventional TURB (cTURB).
OBJECTIVE: To evaluate whether eTURB is superior to cTURB in resection of NMIBC and specimen retrieval.
METHODS: This was a randomized, multicenter trial in patients with up to three cTa-T1 NMIBC tumors of 1-3 cm in size, who were enrolled from January 2019 to January 2022.
METHODS: Participants were randomized 1:1 to undergo eTURB (n = 192) or cTURB (n = 192).
METHODS: The primary outcome was the prevalence of detrusor muscle (DM) in the specimen retrieved. Secondary endpoints included bladder perforation, persistent disease at second-look TURB, positive lateral resection margin, positive deep resection margin, operation time, perforation rate, obturator reflex, conversion from eTURB to cTURB, recurrence-free survival, and disease recurrence at 3 mo.
CONCLUSIONS: A total of 384 patients were randomized to undergo eTURB or cTURB. A total of 452 tumors were resected and analyzed for the primary outcome. eTURB was superior to cTURB in retrieval of DM (80.7% vs 71.1%; mixed-model p = 0.01). Bladder perforation (5.6% vs 12%; difference -6.4%; 95% confidence interval [CI] -12.2% to -0.6%) and obturator reflex (8.4% vs 16%; difference -7.6%; 95% CI -14.3% to -0.9%) were less frequent in the eTURB arm than in the cTURB arm. Operation time did not differ between the two techniques (26 min, interquartile range [IQR] 20-38 for eTURB vs 25 min, IQR 17-35 for cTURB; difference 1 min, 95% CI -25.9 to 4.99). Second-look TURB was performed in 24 patients in the eTURB arm and 34 in the cTURB arm, with no difference in the rate of residual papillary disease (pTa/pT1: 56% vs 55.9%; difference 0.1%, 95% CI -25.5% to 25.7%). At median follow-up of 13 mo (IQR 7-20), 18.4% of the patients in the eTURB arm and 16.7% in the cTURB arm had experienced bladder cancer recurrence (Cox hazard ratio 0.87, 95% CI 0.49-1.52; p = 0.6).
CONCLUSIONS: In patients with clinical NMIBC with up to three tumors of 1-3 cm in size, tumor removal via eTURB resulted in a higher rate of DM in the pathologic specimen in comparison to cTURB. Moreover, eTURB was associated with lower frequency of obturator reflex and bladder perforation than cTURB was. While improving on the quality indicators for NMIBC, the long-term differential oncologic benefits of eTURB remain uncertain.
RESULTS: We compared two techniques for removal of bladder tumors and found that tumor removal in a single piece, called en bloc resection, provides a better-quality specimen for pathology analysis and fewer complications in comparison to the conventional method. This trial is registered at ClinicalTrials.gov as NCT03718754.