Department of Urology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
J Endourol. 2013 Jun;27(6):697-704. doi: 10.1089/end.2012.0694. Epub 2013 Apr 26.
Radiofrequency ablation (RFA) has been considered as an important therapy for small renal lesions. The main limitation of RFA, however, is the lack of pathologic confirmation of complete tumor eradication. A single center, open label, randomized pilot study was designed to evaluate whether contrast-enhanced ultrasonography (CEUS) with Sonovue, performed in real time could allow us to determine the end point during laparoscopic radiofrequency ablation (LRFA) and the clinical outcome of this method.
Ninety-six patients undergoing LRFA were randomly assigned to CEUS or a control group; finally, 38 and 40 patients with a pathologic diagnosis of renal-cell carcinoma completed a 3-month follow-up. CEUS was conducted in real time during the procedure to determine the end point in the CEUS group. The primary outcome was the incomplete ablation rate according to a radiographic image at 3 months after the procedure. The secondary outcome included the local tumor control rate and disease-free survival rate.
There were no differences in the incomplete ablation rate and disease-free survival rate between the two groups. Within a median 16-month follow-up period, three incomplete ablations and two local recurrences according to a radiographic image were found in the control group. Meanwhile, there was no incomplete ablation or recurrence but one lung metastasis in the CEUS group. The local tumor control rate was 87.5% (35/40) in the control group vs 100% (38/38) (P=0.073) in the CEUS group.
In patients undergoing LRFA, there were no differences in the incomplete ablation rate and local tumor control rate between the CEUS group and the control group in our study despite a nonsignificant trend in favor of CEUS. CEUS may have the potential to provide more effective renal tumor ablation. These novel data support the need for a larger study of CEUS during LRFA surgery.
射频消融（RFA）已被认为是治疗小肾肿瘤的重要方法。然而，RFA 的主要局限性是缺乏对完全肿瘤清除的病理确认。本研究为单中心、开放标签、随机试验，旨在评估实时超声造影（CEUS）是否可以帮助我们确定腹腔镜下射频消融（LRFA）的终点，并评估该方法的临床结果。
96 例行 LRFA 的患者被随机分配至 CEUS 组或对照组；最终，38 例和 40 例经病理诊断为肾细胞癌的患者完成了 3 个月的随访。CEUS 组在手术中实时进行，以确定 CEUS 组的终点。主要终点是术后 3 个月的不完全消融率。次要终点包括局部肿瘤控制率和无病生存率。
两组间的不完全消融率和无病生存率无差异。在中位随访 16 个月期间，对照组中根据影像学图像发现 3 例不完全消融和 2 例局部复发。而在 CEUS 组中未发现不完全消融或复发，但有 1 例肺转移。对照组局部肿瘤控制率为 87.5%（35/40），CEUS 组为 100%（38/38）（P=0.073）。
在本研究中，尽管 CEUS 有一定的优势，但在行 LRFA 的患者中，CEUS 组与对照组间的不完全消融率和局部肿瘤控制率无差异。CEUS 可能具有提供更有效的肾肿瘤消融的潜力。这些新数据支持需要更大规模的 CEUS 在 LRFA 手术中的研究。
