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经尿道激光整块切除术与传统切除术治疗大于 3cm 的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.

机构信息

Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia -

Institute for Clinical Medicine Named After N.V. Sklifosovsky, Sechenov University, Moscow, Russia.

出版信息

Minerva Urol Nephrol. 2024 Aug;76(4):436-441. doi: 10.23736/S2724-6051.24.05682-9.

Abstract

BACKGROUND

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.

METHODS

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).

RESULTS

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).

CONCLUSIONS

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.

摘要

背景

整块切除术(ERBT)是一种治疗非肌层浸润性膀胱癌(NMIBC)的手术方法,适用于肿瘤直径小于 3cm 的患者。关于直径大于 3cm 肿瘤的 ERBT 的疗效和安全性的数据较少,且其与传统经尿道膀胱肿瘤切除术(TURBT)的疗效比较尚不清楚。本研究旨在前瞻性比较激光(Tm 光纤)ERBT 和 TURBT 在原发性膀胱病变大于 3cm 的患者中的可行性、安全性和肿瘤学结果。

方法

收集了 2018 年 2 月至 2022 年 3 月期间因原发性 NMIBC 接受手术的 45 例患者的队列进行前瞻性研究。未进行随机分组。所有手术均由两名经验丰富的外科医生完成。纳入标准为:年龄大于 18 岁,原发性 Ta 或 T1 膀胱肿瘤,直径大于 3cm,肿瘤数不超过 3 个,无上尿路尿路上皮癌病史。排除标准为原位癌或侵犯肌层(≥T2)。ERBT 采用铥纤维激光(IPG,俄罗斯)进行。主要终点包括无复发生存率(RFS),随访时间为 3、6 和 12 个月。次要终点为安全性参数、围手术期数据和标本质量(标本中存在肌肉层)。

结果

28 例患者行激光 ERBT,17 例行常规 TURBT。两组肿瘤的位置和大小相似。ERBT 组的成功率为 93.3%,有 2 例从 ERBT 转为 TURBT。ERBT 组有 92.8%的患者存在逼尿肌,而 TURBT 组为 70.5%(P=0.04)。仅在 TURBT 组观察到闭孔神经反射:17.6%比 0.0%(P=0.02)。两组其他并发症的发生率相似。3 个月时(93.9%比 94.1%,P=0.87)、6 个月时(89.3%比 82.3%,P=0.5)和 12 个月时(89.3%比 70.6%,P=0.11),两种方法的 RFS 无统计学差异。

结论

激光 ERBT 是一种治疗直径大于 3cm 的膀胱肿瘤的可行且安全的方法。虽然它似乎比 TURBT 更安全,但它对疗效的影响仍需要更大规模的试验来评估。

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