一项比较透视、全超声及联合引导用于微创经皮肾镜取石术肾穿刺入路的前瞻性随机试验。

A prospective and randomised trial comparing fluoroscopic, total ultrasonographic, and combined guidance for renal access in mini-percutaneous nephrolithotomy.

作者信息

Zhu Wei, Li Jiasheng, Yuan Jian, Liu Yongda, Wan Shaw P, Liu Guanzhao, Chen Wenzhong, Wu Wenqi, Luo Jintai, Zhong Dongliang, Qi Defeng, Lei Ming, Zhong Wen, Zhang Ze, He Zhaohui, Zhao Zhijian, Lu Suilin, Wu Yuji, Zeng Guohua

机构信息

Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.

Guangdong Key Laboratory of Urology, Guangzhou, Guangdong, China.

出版信息

BJU Int. 2017 Apr;119(4):612-618. doi: 10.1111/bju.13703. Epub 2016 Nov 28.

DOI:10.1111/bju.13703

PMID:27862806

Abstract

OBJECTIVE

To compare the safety and efficacy of fluoroscopic guidance (FG), total ultrasonographic guidance (USG), and combined ultrasonographic and fluoroscopic guidance (CG) for percutaneous renal access in mini-percutaneous nephrolithotomy (mini-PCNL).

PATIENTS AND METHODS

The present study was conducted between July 2014 and May 2015 as a prospective randomised trial at the First Affiliated Hospital of Guangzhou Medical University. In all, 450 consecutive patients with renal stones of >2 cm were randomised to undergo FG, USG, or CG mini-PCNL (150 patients for each group). The primary endpoints were the stone-free rate (SFR) and blood loss (haemoglobin decrease during the operation and transfusion rate). Secondary endpoints included access failure rate, operating time, and complications. S.T.O.N.E. score was used to document the complexity of the renal stones. The study was registered at http://clinicaltrials.gov/ (NCT02266381).

RESULTS

The three groups had similar baseline characteristics. With S.T.O.N.E. scores of 5-6 or 9-13, the SFRs were comparable between the three groups. For S.T.O.N.E. scores of 7-8, FG and CG achieved significantly better SFRs than USG (one-session SFR 85.1% vs 88.5% vs 66.7%, P = 0.006; overall SFR at 3 months postoperatively 89.4% vs 90.2% vs 69.8%, P = 0.002). Multiple-tracts mini-PCNL was used more frequently in the FG and CG groups than in the USG group (20.7% vs 17.1% vs 9.5%, P = 0.028). The mean total radiation exposure time was significantly greater for FG than for CG (47.5 vs 17.9 s, P < 0.001). The USG had zero radiation exposure. There was no significant difference in the haemoglobin decrease, transfusion rate, access failure rate, operating time, nephrostomy drainage time, and hospital stay among the groups. The overall operative complication rates using the Clavien-Dindo grading system were similar between the groups.

CONCLUSIONS

Mini-PCNL under USG is as safe and effective as FG or CG in the treatment of simple kidney stones (S.T.O.N.E. scores 5-6) but with no radiation exposure. FG or CG is more effective for patients with S.T.O.N.E. scores of 7-8, where multiple percutaneous tracts may be necessary.

摘要

目的

比较在微创经皮肾镜取石术（mini-PCNL）中，透视引导（FG）、全程超声引导（USG）以及超声与透视联合引导（CG）进行经皮肾穿刺的安全性和有效性。

患者与方法

本研究于2014年7月至2015年5月在广州医科大学第一附属医院进行，为一项前瞻性随机试验。总共450例连续入选的肾结石直径>2 cm的患者被随机分为三组，分别接受FG、USG或CG引导下的mini-PCNL（每组150例患者）。主要终点为结石清除率（SFR）和失血量（术中血红蛋白下降情况及输血率）。次要终点包括穿刺失败率、手术时间及并发症。采用S.T.O.N.E.评分记录肾结石的复杂程度。本研究已在http://clinicaltrials.gov/（NCT02266381）注册。

结果

三组患者的基线特征相似。对于S.T.O.N.E.评分为5 - 6或9 - 13的患者，三组的结石清除率相当。对于S.T.O.N.E.评分为7 - 8的患者，FG组和CG组的结石清除率显著优于USG组（一期结石清除率85.1% vs 88.5% vs 66.7%，P = 0.006；术后3个月总体结石清除率89.4% vs 90.2% vs 69.8%，P = 0.002）。FG组和CG组比USG组更频繁地使用多通道mini-PCNL（20.7% vs 17.1% vs 9.5%，P = 0.028）。FG组的平均总辐射暴露时间显著长于CG组（47.5 vs 17.9秒，P < 0.001）。USG组无辐射暴露。各组间血红蛋白下降、输血率、穿刺失败率、手术时间、肾造瘘引流时间及住院时间无显著差异。采用Clavien-Dindo分级系统评估，各组总体手术并发症发生率相似。