Madersbacher S, Kratzik C, Susani M, Pedevilla M, Marberger M
Department of Urology, University of Vienna, Austria.
Eur Urol. 1998;33(2):195-201. doi: 10.1159/000019555.
The aim of this study was to determine the feasibility and safety of transcutaneous ablation of human testicular tissue by high-intensity focused ultrasound (HIFU).
Transcutaneous ablation of human testicular tissue by HIFU was performed with equipment previously developed for transrectal prostate ablation. This device utilizes a piezoceramic transducer operating at 4.0 MHz with a site-intensity of 1,600-2,000 W/cm2. To study the histological impact of transcutaneous HIFU, tests of 4 patients with prostate cancer were subjected to transcutaneous HIFU-therapy prior to scrotal orchiectomy in a phase I trial. In a phase II clinical trial, 4 patients with the typical sonographic pattern of a tumor in a solitary testis were treated with transcutaneous HIFU as a minimally invasive organ-preserving approach followed by a 6 weeks' course of prophylactic irradiation of the testis with 20 Gy. In all 4 patients, the contralateral testis had been previously removed for testis cancer.
Histologically, HIFU-treated areas exhibited signs of cellular necrosis in all cases (n = 4). The border between viable and necrotic tissue was extremely sharp comprising only 5-7 cell layers. In the phase II clinical study, we aimed to ablate the entire cancer in a single therapeutic HIFU session. HIFU treatment was performed under general anesthesia. As negative side effects we observed a cutaneous thermolesion in 1 individual. One patient refused to undergo postoperative irradiation and developed a local failure. This patient underwent radical orchiectomy. Another patient received two cycles of chemotherapy for a single suspicious retroperitoneal lymph node diagnosed 6 months after HIFU therapy. Three patients are tumor-free with a follow-up of 16, 23 and 31 months, respectively.
This study demonstrates the feasibility and safety of transcutaneous testicular tissue ablation by HIFU. Despite the major drawback of this technique, i.e. that no tumor histology is obtained, we believe that transcutaneous HIFU followed by irradiation has the potential to be established as a minimally invasive treatment alternative to organ-preserving surgery for tumors in a solitary testis.
本研究旨在确定高强度聚焦超声（HIFU）经皮消融人睾丸组织的可行性和安全性。
使用先前开发用于经直肠前列腺消融的设备对人睾丸组织进行HIFU经皮消融。该设备采用工作频率为4.0 MHz、局部强度为1600 - 2000 W/cm²的压电陶瓷换能器。为研究经皮HIFU的组织学影响，在一项I期试验中，4例前列腺癌患者在阴囊睾丸切除术前接受经皮HIFU治疗。在一项II期临床试验中，4例单侧睾丸具有典型肿瘤超声图像的患者接受经皮HIFU治疗，作为一种微创的保留器官方法，随后对睾丸进行为期6周、20 Gy的预防性照射。所有4例患者的对侧睾丸此前均因睾丸癌而被切除。
组织学检查显示，所有病例（n = 4）中HIFU治疗区域均出现细胞坏死迹象。存活组织与坏死组织之间的边界极其清晰，仅包含5 - 7个细胞层。在II期临床研究中，我们旨在通过单次HIFU治疗消融整个肿瘤。HIFU治疗在全身麻醉下进行。作为负面副作用，我们观察到1例出现皮肤热损伤。1例患者拒绝接受术后放疗并出现局部复发。该患者接受了根治性睾丸切除术。另1例患者在HIFU治疗6个月后，因单个可疑的腹膜后淋巴结接受了两个周期的化疗。3例患者在分别随访16、23和31个月时无肿瘤。
本研究证明了HIFU经皮消融睾丸组织的可行性和安全性。尽管该技术存在主要缺点，即无法获得肿瘤组织学结果，但我们认为，经皮HIFU联合放疗有可能成为单侧睾丸肿瘤保留器官手术的一种微创治疗替代方案。
