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NCT07890766
Management of Breast Fibroadenoma: Comparing Observation, Microwave Ablation, and Surgical Excision
Conditions: Fibroadenoma, Breast Fibroadenoma, Benign Breast Disease
Sex: Female
Ages: 18 Years – 40 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Sohag University
Location: Sohag University Hospital Sohag
Summary
The purpose of this study is to evaluate and compare three different management strategies for benign breast fibroadenoma: conservative management with clinical and radiological follow-up (observation), ultrasound-guided percutaneous microwave ablation (MWA), and conventional open surgical excision.
Fibroadenoma is the most common benign solid breast tumor in young women. While conventional surgical excision provides complete tissue removal, it may result in visible surgical scars, breast volume loss, and contour deformity. Minimally invasive thermal techniques such as microwave ablation offer potential advantages in tissue preservation and cosmetic satisfaction under local anesthesia. This study aims to assess and compare the therapeutic success, safety, postoperative pain, recovery period, complication rates, and cosmetic outcomes among female patients undergoing these three approaches at Sohag University Hospital.
Eligibility Criteria
Inclusion Criteria:
* Female patients aged 18 to 40 years.
* Histologically confirmed breast fibroadenoma on ultrasound-guided core needle biopsy with concordant imaging features classified as BI-RADS 2 or 3.
* Lesion size of 1.0 cm to 4.0 cm in maximum diameter on baseline ultrasound measurement.
* Lesion requiring active intervention based on at least one of: documented progressive growth during surveillance, local symptoms (pain, discomfort, or compression), cosmetic concern, or patient preference/refusal of further conservative management.
* Minimum distance of 1.0 cm from the lesion to the skin surface, nipple-areola complex, and pectoralis fascia on ultrasound in the supine position.
Exclusion Criteria:
* Histological features of phyllodes tumor, cellular atypia, or malignancy on core needle biopsy.
* BI-RADS category 4 or higher on pre-procedure imaging.
* Pregnancy or current lactation.
* Previous ipsilateral breast surgery, radiotherapy, or ablative procedure.
* Presence of breast implants.
* Severe uncorrectable coagulopathy or clinical unfitness for interventional/surgical procedure.
Source: ClinicalTrials.gov (NCT07890766). StuddyBuddy aggregates publicly available trial information.