研读一刻 | 7.5Fr一次性输尿管镜应用于输尿管镜术和激光碎石术的安全性和有效性:一项多中心前瞻性初步研究

文章题目 | 7.5Fr一次性输尿管镜应用于输尿管镜术和激光碎石术的安全性和有效性:一项多中心前瞻性初步研究

发表期刊 | Central European Journal of Urology

关键词 | 肾结石，输尿管镜术，一次性镜，临床结果，激光

近日，一篇名为《7.5Fr一次性输尿管镜应用于输尿管镜术和激光碎石术的安全性和有效性:一项多中心前瞻性初步研究》的论文发表于Central European Journal of Urology（CEJU）。该论文由多个欧洲知名泌尿外科研究中心在使用HugeMed HU30S（7.5/3.6Fr）进行临床手术后联合发表，文章结论提到：多中心研究证实了使用7.5 Fr一次性输尿管软镜治疗泌尿系统结石的安全性和有效性。

以下为摘要部分:

随着微创腔内泌尿外科技术的引入，肾结石疾病(KSD)的治疗有了显著的发展。随着技术的进步，特别是从光纤到电子的转变、一次性使用体系的转变、以及小直径器械的研制，提升了结石治疗的术中视野体验和疗效。一次性镜的小型化代表了最近的创新成果，在许多方面提供了潜在的优势，尤其是在某些极具挑战性的情况下。

然而，关于其安全性和临床结果的证据有限。本研究旨在评估使用7.5 Fr一次性输尿管软镜治疗结石时的有效性和安全性。

Introduction: The treatment of kidney stone disease (KSD) has evolved significantly with the introduction of minimally invasive endourological techniques. Advancements in technology, particularly the transition from fibreoptic to digital and single use systems and the development of smaller-diameter instruments, has improved intraoperative view and efficacy in stone treatment. The miniaturization in single-use scopes represent a recent innovation, offering potential benefits, especially in challenging cases. 

However, there is limited evidence on their safety and clinical outcomes. This study aims to evaluate the efficacy and safety of stone treatment using a single-use 7.5 Fr flexible ureteroscope.

这一系列接受使用7.5 Fr一次性输尿管软镜进行输尿管软镜术的泌尿系统结石患者，来自五个三级腔内泌尿外科中心。前瞻性地收集和分析了患者的人口统计学、结石特征、术中和术后结果的数据。手术由经验丰富的腔内泌尿外科医生按照标准方案进行。

Material and methods: Consecutive patients with urinary stones undergoing flexible ureteroscopy with a 7.5 Fr single-use flexible ureteroscope across five tertiary endourology centers were included. Data on patient demographics, stone characteristics, intra- and postoperative outcomes were prospectively collected and analyzed. Procedures were performed by experienced endourology surgeons following standard protocols.

50例平均年龄54.5岁（IQR四分位距：25–65.8岁）、男女比例为34：16的患者接受了输尿管软镜术。平均累积结石大小为18.9毫米（SD标准差 ±10.9 mm），平均结石体积为2031.2 mm³（SD标准差 ±2869.4 mm³），平均Hounsfield单位为1087.4 (SD标准差 ±384.9)。36例(72%)有多处结石，其中进行了双侧FURS的有9例(18%)。24例患者(48%)术前植入了支架。22例(44%)患者使用了输尿管导引鞘，46例(92%)患者术后插入了支架。

中位手术时间为60分钟（IQR:53–90），32例患者（64%）首次手术后结石排空（小于2 cm和≥2 cm结石的SFR清石率 stone free rate分别为85.2%和36.2%），3例患者（6%）出现围手术期并发症和术后并发症（Clavien ≤II）。

Results: 50 patients with a mean age of 54.5 years (IQR: 25–65.8) and a male to female ratio of 34:16 underwent flexible ureteroscopy (FURS). Mean cumulative stone size was 18.9 mm (SD ±10.9 mm) with a mean stone volume of 2031.2 mm³ (SD ±2869.4 mm³) and mean Hounsfield units of 1087.4 (SD ±384.9). 36 (72%) had multiple stones and a bilateral FURS was performed in 9 cases (18%). 24 patients (48%) had a preoperative stent inserted. A ureteral access sheath was used in 22 (44%) cases and 46 (92%) patients had a postoperative stent inserted.

The median operative time was 60min (IQR: 53–90), 32 patients (64%) were stone free after the first procedure (SFR for <2 cm and ≥2 cm stones was 85.2% and 36.2% respectively), perioperative and postoperative complications (Clavien ≤II) were observed in 3 patients (6%).

多中心研究证实了使用7.5 Fr一次性输尿管软镜治疗泌尿系统结石的安全性和有效性。尽管结果很有希望，但还需要更大规模的研究来进一步验证这些发现。

Conclusions: This multicentric study demonstrates the safety and efficacy of using the 7.5Fr single-use flexible ureteroscope for urinary stone treatment.While the results are promising, larger studies are needed to validate these findings further.

本次研究多个中心分别为：

奥地利 | 维也纳医科大学综合癌症中心泌尿外科

Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria 

英国 | 南安普敦大学医院 NHS 信托基金

University Hospital Southampton NHS Trust, Southampton, United Kingdom 

欧洲泌尿外科协会

EAU Section on Urolithiasis (EULIS) 

比利时 | AZ KLINA医疗中心泌尿外科

Department of Urology, AZ Klina, Brasschaat, Belgium

荷兰 | 阿姆斯特丹大学 阿姆斯特丹 UMC 医疗中心 泌尿外科

Department of Urology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands

西班牙 | 巴塞罗那自治大学 Fundació Puigvert医院 泌尿外科

Department of Urology, Fundació Puigvert, Autonoma University of Barcelona, Barcelona, Spain

比利时 | 根特大学医院 ERN eUROGEN 认证中心 泌尿外科

Department of Urology, ERN eUROGEN Accredited Centre, University Hospital Ghent, Ghent, Belgium

想了解更多详情，请看原文：

https://ceju.online/journal/2024/kidney-calculi-ureteroscopy-singleuse-scope-clinical-outcomes-laser-2358.php