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比较零缺血腹腔镜射频消融辅助肿瘤剜除术与腹腔镜肾部分切除术治疗 T1a 期肾癌:一项随机临床试验。

Comparing Zero Ischemia Laparoscopic Radio Frequency Ablation Assisted Tumor Enucleation and Laparoscopic Partial Nephrectomy for Clinical T1a Renal Tumor: A Randomized Clinical Trial.

机构信息

Department of Urology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.

Department of Urology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.

出版信息

J Urol. 2016 Jun;195(6):1677-83. doi: 10.1016/j.juro.2015.12.115. Epub 2016 Feb 22.

Abstract

PURPOSE

We evaluated the functional outcome, safety and efficacy of zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation compared with conventional laparoscopic partial nephrectomy.

MATERIALS AND METHODS

A prospective randomized controlled trial was conducted from April 2013 to March 2015 in patients with cT1a renal tumor scheduled for laparoscopic nephron sparing surgery. All patients were followed for at least 12 months. Patients in the laparoscopic radio frequency ablation assisted tumor enucleation group underwent tumor enucleation after radio frequency ablation without hilar clamping. The primary outcome was the change in glomerular filtration rate of the affected kidney by renal scintigraphy at 12 months. Secondary outcomes included changes in estimated glomerular filtration rate, estimated blood loss, operative time, hospital stay, postoperative complications and oncologic outcomes. The Pearson chi-square or Fisher exact, Student t-test and Wilcoxon rank sum tests were used.

RESULTS

The trial ultimately enrolled 89 patients, of whom 44 were randomized to the laparoscopic radio frequency ablation assisted tumor enucleation group and 45 to the laparoscopic partial nephrectomy group. In the laparoscopic partial nephrectomy group 1 case was converted to radical nephrectomy. Compared with the laparoscopic partial nephrectomy group, patients in the laparoscopic radio frequency ablation assisted tumor enucleation group had a smaller decrease in glomerular filtration rate of the affected kidney at 3 months (10.2% vs 20.5%, p=0.001) and 12 months (7.6% vs 16.2%, p=0.002). Patients in the laparoscopic radio frequency ablation assisted tumor enucleation group had a shorter operative time (p=0.002), lower estimated blood loss (p <0.001) and a shorter hospital stay (p=0.029) but similar postoperative complications (p=1.000). There were no positive margins or local recurrence in this study.

CONCLUSIONS

Zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation enables tumor excision with better renal function preservation compared to conventional laparoscopic partial nephrectomy. Less blood loss and a shorter operative time were achieved with similar postoperative complication rates.

摘要

目的

我们评估了零缺血腹腔镜射频消融辅助肿瘤剜除术与传统腹腔镜部分肾切除术的功能结果、安全性和疗效。

材料与方法

2013 年 4 月至 2015 年 3 月,对计划行腹腔镜保肾手术的 cT1a 肾癌患者进行了前瞻性随机对照试验。所有患者均随访至少 12 个月。腹腔镜射频消融辅助肿瘤剜除组患者在射频消融后不夹闭肾门行肿瘤剜除。主要结局是肾闪烁扫描 12 个月时受影响肾脏肾小球滤过率的变化。次要结局包括估算肾小球滤过率、估计失血量、手术时间、住院时间、术后并发症和肿瘤学结局的变化。采用 Pearson χ2 或 Fisher 确切检验、Student t 检验和 Wilcoxon 秩和检验。

结果

该试验最终纳入 89 例患者,其中 44 例随机分为腹腔镜射频消融辅助肿瘤剜除组和腹腔镜部分肾切除术组。腹腔镜部分肾切除术组中有 1 例转为根治性肾切除术。与腹腔镜部分肾切除术组相比,腹腔镜射频消融辅助肿瘤剜除组患者在 3 个月(10.2%比 20.5%,p=0.001)和 12 个月(7.6%比 16.2%,p=0.002)时受影响肾脏肾小球滤过率下降较小。腹腔镜射频消融辅助肿瘤剜除组患者的手术时间较短(p=0.002),估计失血量较少(p<0.001),住院时间较短(p=0.029),但术后并发症发生率相似(p=1.000)。本研究中无阳性切缘或局部复发。

结论

与传统腹腔镜部分肾切除术相比,零缺血腹腔镜射频消融辅助肿瘤剜除术可在保留肾功能方面更好地进行肿瘤切除。术中失血量少,手术时间短,术后并发症发生率相似。

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