经尿道激光整块切除术与传统切除术治疗大于 3 厘米膀胱肿瘤的前瞻性非随机比较。
Prospective non-randomized comparison of transurethral laser en bloc resection vs. conventional resection of bladder tumors larger than 3 cm.
发表日期:2024 Aug
作者:
Vladislav Petov, Ekaterina Timofeeva, Roman Sukhanov, Jack Baniel, Mansur Mustafin, Harun Fajkovic, Andrey Morozov, Jeremy Y Teoh, Nirmish Singla, Ekaterina Laukhtina, Thomas R Herrmann, Shahrokh F Shariat, Dmitry Enikeev
来源:
Minerva Urology and Nephrology
摘要:
膀胱肿瘤整块切除术(ERBT)是一种针对肿瘤小于3厘米的非肌层浸润性膀胱癌(NMIBC)患者的既定手术治疗方法。关于 ERBT 对大于 3 cm 肿瘤的疗效和安全性的数据很少,其与传统经尿道切除术 (TURBT) 相比的疗效仍不清楚。本研究的目的是前瞻性比较激光(Tm 光纤)ERBT 和 TURBT 在原发性膀胱病变≥3 cm 患者中的可行性、安全性和肿瘤学结果。队列由 2018 年 2 月期间接受原发性 NMIBC 手术的 45 名患者组成2022 年 3 月是前瞻性收集的。没有随机化。所有手术均由两名经验丰富的外科医生完成。纳入标准为:年龄>18岁,原发性Ta或T1期膀胱肿瘤,直径≥3 cm,肿瘤数量不超过3个,无上尿路尿路上皮癌病史。排除标准是原位癌或侵入肌肉层(≥T2)。 ERBT 使用铥光纤激光器(IPG,俄罗斯)进行。主要终点包括 3、6 和 12 个月无复发生存 (RFS) 的疗效。次要终点是安全参数、围手术期数据和标本质量(标本中是否存在肌肉层)。28 名患者接受了激光 ERBT,17 名患者接受了传统 TURBT。两组的肿瘤位置和大小相当。 ERBT组成功率为93.3%,有2例ERBT转TURBT。 ERBT 组中 92.8% 的患者存在逼尿肌,而 TURBT 组中这一比例为 70.5%(P=0.04)。仅在 TURBT 组中观察到闭孔神经反射:17.6% vs. 0.0% (P=0.02)。两组之间其他并发症的发生率相当。两种方法在 3 个月(93.9% vs. 94.1%,P=0.87)、6 个月(89.3% vs. 82.3%,P=0.5)和 12 个月(89.3% vs. 70.6%,P=0.5)时的 RFS 没有统计学差异。 0.11). 激光 ERBT 是治疗大于 3 厘米的膀胱肿瘤的可行且安全的手术。虽然它似乎比 TURBT 更安全,但其对疗效的影响仍有待在更大规模的试验中评估。
En bloc resection of bladder tumor (ERBT) is an established surgical treatment method for patients with non-muscle invasive bladder cancer (NMIBC) in tumors less than 3 cm. Data regarding the efficacy and safety of ERBT on larger than 3 cm tumors are sparse and its efficacy compared to conventional transurethral resection (TURBT) remains unclear. The aim of this study was to prospectively compare the feasibility, safety and oncological outcomes of laser (Tm-fiber) ERBT and TURBT in patients with primary bladder lesions ≥3 cm.A cohort of 45 patients who underwent surgery for primary NMIBC between February 2018 and March 2022 was collected prospectively. There was no randomization. All procedures were performed by two experienced surgeons. Inclusion criteria were as follows: age >18 years, primary Ta or T1 bladder tumor with a diameter of ≥3 cm, no more than 3 tumors and no history of upper tract urothelial carcinoma. Exclusion criteria were carcinoma in situ or invasion into muscle layer (≥T2). ERBT was performed with thulium fiber laser (IPG, Russia). Primary endpoints included efficacy with recurrence-free survival (RFS) at 3, 6 and 12 months. Secondary endpoints were safety parameters, perioperative data and specimen quality (the presence of muscle layer in specimens).Twenty-eight patients underwent laser ERBT and 17 conventional TURBT. The location and size of the tumors were comparable in both groups. The success rate was 93.3% in the ERBT group with two cases of conversion from ERBT to TURBT. Detrusor muscle was present in 92.8% patients in the ERBT group versus 70.5% in the TURBT group (P=0.04). Obturator nerve reflex was observed only in the TURBT group: 17.6% vs. 0.0% (P=0.02). The frequency of other complications was comparable between the two groups. RFS was not statistically different between the two methods at 3 (93.9% vs. 94.1%, P=0.87), 6 (89.3% vs. 82.3%, P=0.5) and 12 months (89.3% vs. 70.6%, P=0.11).Laser ERBT is a feasible and safe procedure to manage bladder tumors larger than 3 cm. While it seems safer than TURBT, its effect on efficacy remains to be assessed in larger trials.