Peek Mirjam C L, Ahmed Muneer, Douek Michael
Research Oncology, Division of Cancer Studies, King's College London, Guy's Hospital Campus, Great Maze Pond, London, SE1 9RT Great Britain UK.
J Ther Ultrasound. 2015 Apr 14;3:6. doi: 10.1186/s40349-015-0027-6. eCollection 2015.
Breast fibroadenomata (FAD) are the most common benign lesions in women. For palpable lesions, there are currently three standard treatment options: reassurance (with or without follow-up), vacuum-assisted mammotomy (VAM) or surgical excision. High-intensity focused ultrasound (HIFU) ablation has been used in the treatment of FAD. The drawback of HIFU is its prolonged treatment duration. The aim of this trial is to evaluate circumferential HIFU treatment for the effective ablation of FAD with a reduced treatment time.
METHODS/DESIGN: Fifty patients (age ≥18 years) will be recruited with symptomatic FAD, visible on ultrasound (US, grade U2 benign). In patients ≥25 years, cytology or histology will be performed to confirm the diagnosis of a FAD. These patients will receive HIFU treatment using the US-guided Echopulse device (Theraclion Ltd., Malakoff, France) under local anaesthesia. An additional 50 patients will be recruited and contacted 6 months after discharge from the breast clinic. These patients will be offered an US scan to determine the change in size of their FAD. This natural change in size will be compared to the decrease in size after HIFU treatment. Secondary outcome measures include post-treatment complications, patient recorded outcome measures, mean treatment time and cost analysis.
Current Controlled Trials: ISRCTN76622747.
乳腺纤维腺瘤是女性最常见的良性病变。对于可触及的病变，目前有三种标准治疗选择：观察（有无随访）、真空辅助乳腺切除术（VAM）或手术切除。高强度聚焦超声（HIFU）消融已用于乳腺纤维腺瘤的治疗。HIFU的缺点是治疗时间长。本试验的目的是评估环形HIFU治疗能否在缩短治疗时间的情况下有效消融乳腺纤维腺瘤。
方法/设计：将招募50例有症状的乳腺纤维腺瘤患者（年龄≥18岁），超声（US，U2级良性）可见。年龄≥25岁的患者将进行细胞学或组织学检查以确诊乳腺纤维腺瘤。这些患者将在局部麻醉下使用超声引导的Echopulse设备（法国马勒科夫的Theraclion有限公司）接受HIFU治疗。另外50例患者将在乳腺门诊出院6个月后招募并联系。这些患者将接受超声扫描以确定其乳腺纤维腺瘤大小的变化。这种大小的自然变化将与HIFU治疗后的大小减小进行比较。次要结局指标包括治疗后并发症、患者记录的结局指标、平均治疗时间和成本分析。
当前对照试验：ISRCTN76622747。
