Abstract：
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 (p < .001).
Ultrasound-guided HIFU surgery is an effective and safe noninvasive alternative technique for the treatment of 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 (p < .001).
Ultrasound-guided HIFU surgery is an effective and safe noninvasive alternative technique for the treatment of breast fibroadenoma.
摘要：
■这项非随机前瞻性临床试验旨在评估疗效，超声引导下高强度聚焦超声(USgHIFU)手术治疗乳腺纤维腺瘤的安全性和随访结果.
■经机构伦理委员会批准和书面知情同意书，我们共招募了在我院通过芯针活检诊断为乳腺纤维腺瘤的113例患者.在局部麻醉下进行USgHIFU手术。进行了对比增强超声（CEUS）或对比增强MRI（CEMRI）来评估非灌注体积（NPV）。对患者进行体检和超声成像随访。
■在这项研究中分析了85例147例纤维腺瘤患者的临床结局，随访时间超过3个月。52个病人有一个病变,21例患者有2个病灶,12例患者有2个以上病灶.在USgHIFU期间，所有纤维腺瘤的中位定位时间为3（四分位距：1，5）分钟，中位治疗时间为9（四分位距：5，15）分钟。在局部麻醉下,所有患者对治疗耐受性良好。在任何患者中均未观察到严重的表皮烧伤。基于CEUS或CEMRI成像评估，净现值比率中位数为100%(四分位数间距：79.2%，116.8%）。VRR为26.77±50.05%,3-6个月50.22±42.01%和72.74±35.39%，6-12个月和>12个月，分别,差异有统计学意义(p<.001)。
■超声引导下的HIFU手术是治疗乳腺纤维腺瘤的一种有效且安全的无创替代技术。
■经机构伦理委员会批准和书面知情同意书，我们共招募了在我院通过芯针活检诊断为乳腺纤维腺瘤的113例患者.在局部麻醉下进行USgHIFU手术。进行了对比增强超声（CEUS）或对比增强MRI（CEMRI）来评估非灌注体积（NPV）。对患者进行体检和超声成像随访。
■在这项研究中分析了85例147例纤维腺瘤患者的临床结局，随访时间超过3个月。52个病人有一个病变,21例患者有2个病灶,12例患者有2个以上病灶.在USgHIFU期间，所有纤维腺瘤的中位定位时间为3（四分位距：1，5）分钟，中位治疗时间为9（四分位距：5，15）分钟。在局部麻醉下,所有患者对治疗耐受性良好。在任何患者中均未观察到严重的表皮烧伤。基于CEUS或CEMRI成像评估，净现值比率中位数为100%(四分位数间距：79.2%，116.8%）。VRR为26.77±50.05%,3-6个月50.22±42.01%和72.74±35.39%，6-12个月和>12个月，分别,差异有统计学意义(p<.001)。
■超声引导下的HIFU手术是治疗乳腺纤维腺瘤的一种有效且安全的无创替代技术。
