Department of Breast Surgery, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.
State Key Laboratory of Ultrasound in Medicine and Engineering, College of Biomedical Engineering, Chongqing Medical University, Chongqing, China.
Int J Hyperthermia. 2023;40(1):2240548. doi: 10.1080/02656736.2023.2240548.
This nonrandomized prospective clinical trial aimed to assess the efficacy, safety and follow-up outcomes of ultrasound-guided high-intensity focused ultrasound (USgHIFU) surgery in patients with breast fibroadenoma.
With the approval of the institutional ethics committee and written informed consent, a total of 113 patients diagnosed with breast fibroadenoma by core-needle biopsy in our hospital were recruited. USgHIFU surgery was performed under local anesthesia. Contrast-enhanced ultrasound (CEUS) or contrast-enhanced MRI (CEMRI) was performed to evaluate the nonperfused volume (NPV). The patients were followed up with physical examination and ultrasound imaging.
The clinical outcome of 85 patients with 147 fibroadenomas with a follow-up time of more than 3 months was analyzed in this study. Fifty-two patients had one lesion, twenty-one patients had two lesions and twelve patients had more than two lesions. During USgHIFU, the median localization time for all fibroadenomas was 3 (interquartile range: 1, 5) min, and the median treatment time was 9 (interquartile range: 5, 15) min. Under local anesthesia, all the patients tolerated the treatment well. No serious epidermal burns were observed in any of the patients. Based on CEUS or CEMRI imaging evaluation, the median NPV ratio was 100% (interquartile range: 79.2%, 116.8%). The VRR were 26.77 ± 50.05%, 50.22 ± 42.01% and 72.74 ± 35.39% at 3-6 months, 6-12 months and >12 months, respectively, which showed significant statistical difference ( < .001).
Ultrasound-guided HIFU surgery is an effective and safe noninvasive alternative technique for the treatment of breast fibroadenoma.
本非随机前瞻性临床试验旨在评估超声引导高强度聚焦超声（USgHIFU）手术治疗乳腺纤维腺瘤患者的疗效、安全性和随访结果。
经我院经皮穿刺活检确诊为乳腺纤维腺瘤的 113 例患者，在获得机构伦理委员会批准和书面知情同意后，纳入本研究。在局部麻醉下进行 USgHIFU 手术。采用对比增强超声（CEUS）或对比增强磁共振成像（CEMRI）评估无灌注体积（NPV）。通过体格检查和超声影像学进行随访。
本研究分析了 85 例 147 个乳腺纤维腺瘤患者的临床结局，随访时间超过 3 个月。52 例患者有 1 个病灶，21 例患者有 2 个病灶，12 例患者有 2 个以上病灶。在 USgHIFU 过程中，所有纤维腺瘤的中位定位时间为 3（四分位间距：1，5）min，中位治疗时间为 9（四分位间距：5，15）min。在局部麻醉下，所有患者均能耐受治疗。所有患者均未观察到严重的表皮烧伤。根据 CEUS 或 CEMRI 影像学评估，中位 NPV 比值为 100%（四分位间距：79.2%，116.8%）。在 3-6 个月、6-12 个月和>12 个月时，VRR 分别为 26.77±50.05%、50.22±42.01%和 72.74±35.39%，差异具有统计学意义（ < .001）。
超声引导 HIFU 手术是治疗乳腺纤维腺瘤的一种有效且安全的非侵入性替代技术。
