Value of Ultrasound-Guided Microwave Ablation for Breast Fibroadenoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 主要终点
- assess the efficacy of MWA in reducing fibroadenoma volume
研究概览
简要总结
assess the efficacy of MWA in reducing fibroadenoma volume and achieving complete lesion regression at 12 months post-treatment
详细描述
Breast fibroadenomas are commonly seen among women worldwide, with the incidence having increased over the past few decades. The breast fibroadenoma arise due to proliferation of ductal or lobular tissue, and their treatment is controversial. Small asymptomatic breast lesions generally do not require treatment, and some surgeons tend to favor conservative management of breast fibroadenoma with regular follow-up, which should be accompanied by auxiliary examination (i.e., ultrasound and/or mammography and pathological assessment) every 3-6 months in order to dynamically monitor the status of breast lesions. However, some patients with large-sized breast fibroadenomas suffering from pain or anxiety are not satisfied with the conservative management approach and seek for treatment. Thus, it is necessary to excise part of the breast fibroadenoma according to therapeutic options that depend on different presenting situations Surgical resection is the most effective treatment option for patients suffering from breast lesions, although it is an invasive procedure. The patients much prefer a better cosmetic outcome and fewer surgically associated complications, which are commonly associated with minimally invasive procedures. Ultrasound-guided percutaneous microwave ablation (MWA) is a new minimally invasive treatment technology used in breast fibroadenoma and has emerged as a hot topic of clinical exploration in recent years. MWA has already shown promising results in treating liver carcinoma and pulmonary tumors, and in the settings of adrenal and renal malignancies Currently, in relation to benign lesions, MWA is considered a promising treatment option for patients with benign thyroid nodules given its advantage of being minimally invasive, scar-free, and relatively safe, and is associated with fewer post-operative complications.
To the best of our knowledge, MWA, as a thermal ablation technique, is increasingly being accepted by surgeons and clearly needs to be evaluated
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants ≥ 18 years
- •Diagnosed with fibroadenoma by clinical and ultrasonographic signs, core needle biopsy done only if atypical fibroadenoma.
- •Lesion(s) measurable by ultrasound (e.g., diameter 0.7 - 3.0 cm),distance from breast lesion to the skin and pectoralis muscle exceeding 10 mm and the lesion away from nipple areola area .
- •Symptomatic lesion or patient preference for minimally invasive treatment
排除标准
- •Malignancy or high suspicion of malignancy, BIRADs 4 or more/if pathological proved.
- •Active infection.
- •Coagulopathy or contraindications to ablation.
- •Distance from breast lesion to the skin and pectoralis muscle less than 10 mm and the lesion near nipple areola area .
结局指标
主要结局
assess the efficacy of MWA in reducing fibroadenoma volume
时间窗: 12 months
Volume Reduction Ratio (VRR): Calculated to see how much the fibroadenoma has shrunk. Measure 3 orthogonal diameter, calculate volume: L x W x H x0.5 and compare to previous exam.
To evaluate the safety profile of MWA (adverse events, complications).
时间窗: 18 months
the investigators will follow up the patients for any appearance of unwanted changes or any complications
次要结局
- Cosmetic outcome - breast shape and symmetry(18 months)
- Cosmetic outcome - scar appearance(18 months)
- Cosmetic outcome - skin pigmentation changes(18 months)
- Patient satisfaction(18 months)
研究者
Asmaa Mohammed Abdel Hamed Ali
doctor
Assiut University