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新型450纳米蓝光二极管激光与等离子动力电切术用于非肌层浸润性膀胱癌经尿道切除术的疗效与安全性:一项多中心随机对照试验的方案及结果

Efficacy and safety of a novel 450 nm blue diode laser versus plasmakinetic electrocautery for the transurethral resection of non-muscle invasive bladder cancer: The protocol and result of a multicenter randomized controlled trial.

作者信息

Wu Kaijie, Jiang Dali, Zhang Lianhua, Jiang Shuai, Lin Tianhai, Luo Yi, Fan Jinhai, Yang Tao, Chen Haige, Zhang Peng, Wang Xinghuan, Wei Qiang, Guo Jianming, Huang Yiran, He Dalin

机构信息

Department of Urology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an,  China.

Department of Urology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai,  China.

出版信息

Front Oncol. 2023 Jan 17;12:1065735. doi: 10.3389/fonc.2022.1065735. eCollection 2022.

DOI:10.3389/fonc.2022.1065735
PMID:36733358
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9887014/
Abstract

OBJECTIVES

To be the first to apply a novel 450 nm blue diode laser in transurethral resection of bladder tumor (TURBt) to treat patients with non-muscle invasive bladder cancer (NMIBC) and evaluate its efficacy and safety during the preoperative period compared to the conventional plasmakinetic electrocautery.

MATERIALS AND METHODS

Randomized controlled trial (RCT) in five medical centers was designed as a non-inferiority study and conducted from October 2018 to December 2019. Patients with NMIBC were randomized to the blue laser or plasmakinetic electrocautery group for TURBt. As the first study to evaluate this novel blue laser device, the primary outcome was the effective resection rate of bladder tumors, including effective dissection and hemostasis. The secondary outcomes were the perioperative records, including surgical time, postoperative indwelling catheter time, hospital stay length, blood loss, reoperation rate, wound healing and adverse events.

RESULTS

A total of 174 patients were randomized to either the blue laser group (85 patients) or plasmakinetic electrocautery group (89 patients). There was no statistical significance in the clinical features of bladder tumors, including tumor site, number and maximum lesion size. Both the blue laser and plasmakinetic electrocautery could effectively dissect all visible bladder tumors. The surgical time for patients in the blue laser group was longer (p=0.001), but their blood loss was less than that of patients in the control group (p=0.003). There were no differences in the postoperative indwelling catheter time, hospital stay length, reoperation rate or other adverse events. However, the patients undergoing TURBt with the blue laser showed a faster wound healing at 3 months after operation.

CONCLUSION

The novel blue laser could be effectively and safely used for TURBt in patients with NMIBC, and this method was not inferior to plasmakinetic electrocautery during the perioperative period. However, TURBt with the blue laser may provide the benefit to reduce preoperative blood loss and accelerate postoperative wound healing. Moreover, longer follow-up to confirm recurrence-free survival benefit was required.

摘要

目的

首次将新型450纳米蓝色二极管激光应用于膀胱肿瘤经尿道切除术(TURBt),以治疗非肌层浸润性膀胱癌(NMIBC)患者,并在术前阶段将其疗效和安全性与传统等离子动力电切术进行比较。

材料与方法

在五个医疗中心进行的随机对照试验(RCT)被设计为一项非劣效性研究,于2018年10月至2019年12月开展。将NMIBC患者随机分为蓝色激光组或等离子动力电切术组进行TURBt。作为评估这种新型蓝色激光设备的第一项研究,主要结局是膀胱肿瘤的有效切除率,包括有效切除和止血。次要结局是围手术期记录,包括手术时间、术后留置导尿管时间、住院时间、失血量、再次手术率、伤口愈合情况及不良事件。

结果

共有174例患者被随机分为蓝色激光组(85例)或等离子动力电切术组(89例)。膀胱肿瘤的临床特征,包括肿瘤部位、数量和最大病变尺寸,均无统计学意义。蓝色激光和等离子动力电切术均能有效切除所有可见的膀胱肿瘤。蓝色激光组患者的手术时间较长(p = 0.001),但其失血量少于对照组患者(p = 0.003)。术后留置导尿管时间、住院时间、再次手术率或其他不良事件方面无差异。然而,接受蓝色激光TURBt的患者术后3个月伤口愈合更快。

结论

新型蓝色激光可有效、安全地用于NMIBC患者的TURBt,且该方法在围手术期并不劣于等离子动力电切术。然而,蓝色激光TURBt可能有助于减少术前失血量并加速术后伤口愈合。此外,需要更长时间的随访以确认无复发生存获益。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/125e/9887014/b526d6bb04f5/fonc-12-1065735-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/125e/9887014/9b44d84f0be6/fonc-12-1065735-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/125e/9887014/b526d6bb04f5/fonc-12-1065735-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/125e/9887014/9b44d84f0be6/fonc-12-1065735-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/125e/9887014/b526d6bb04f5/fonc-12-1065735-g002.jpg

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