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| 零缺血比较腹腔镜射频消融辅助肿瘤剜除术和腹腔镜肾部分切除术治疗肾肿瘤临床T1a期随机临床试验 Comparing Zero Ischemia Laparoscopic Radio Frequency Ablation Assisted Tumor Enucleation and Laparoscopic Partial Nephrectomy for Clinical T1a Renal Tumor- A Randomized Clinical Trial
摘要 PURPOSE: 目的： We evaluated the functional outcome, safety and efficacy of zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation compared with conventional laparoscopic partial nephrectomy. 我们评估的功能，安全性和零缺血腹腔镜射频消融辅助肿瘤剜除术与常规腹腔镜肾部分切除术疗效比较。 MATERIALS AND METHODS: 材料与方法： 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. 一项前瞻性随机对照试验，是从2013年四月至2015年三月进行ct1a肾肿瘤患者择期行腹腔镜保留肾单位手术。所有患者均随访至少12个月。在腹腔镜下射频消融辅助肿瘤剜除术组患者射频消融不阻断后，行肿瘤剜除术。主要成果是改变在受影响的肾脏肾小球滤过率在12个月的肾动态显像。次要终果包括在估计肾小球滤过率、估计失血量、手术时间、住院时间、术后并发症及疗效。皮尔森卡方检验或Fisher精确，用t检验和Wilcoxon等级测试检验。 RESULTS: 结果: 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. 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术组和45组的腹腔镜肾部分切除术。在腹腔镜下肾部分切除组1例中转为根治性肾切除。随着腹腔镜肾部分切除术组比较，在腹腔镜下射频消融辅助肿瘤剜除术组患者在3个月内曾在受影响的肾脏肾小球滤过率下降（10.2% vs 20.5%，P = 0.001）和12个月（7.6% vs 16.2%，P = 0.002）。在腹腔镜下射频消融辅助肿瘤剜除术组患者的手术时间短（P = 0.002），较低的估计失血量（P＜0.001），和住院时间较短（P = 0.029）但类似的术后并发症（P = 1）。在本研究中，没有切缘阳性或局部复发。 CONCLUSIONS: 结论： 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. 零缺血腹腔镜射频消融辅助肿瘤剜除术使肿瘤切除术较传统腹腔镜肾部分切除术更好的保护肾功能。术后并发症少、出血量少、手术时间短、术后并发症少。 原文： |
