An interventional study of Ultrasound-guided percutaneous microwave ablation and Conventional open surgical excision in Fibroadenoma, Breast Fibroadenoma and Benign Breast Disease, sponsored by Sohag University. Not yet recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Sohag University · Not applicable, Interventional, and Treatment
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.
Fibroadenoma is a common benign fibroepithelial breast neoplasm predominantly affecting women of reproductive age. Although benign, symptomatic or enlarging lesions frequently cause significant anxiety, pain, and cosmetic concern. Standard management has traditionally relied on either watchful waiting or open surgical excision. While surgery allows definitive histological evaluation, it can lead to scarring and breast tissue defects. Ultrasound-guided percutaneous microwave ablation (MWA) has emerged as an effective, breast-preserving alternative that induces coagulative necrosis of the tumor under local anesthesia with minimal collateral tissue damage.
This comparative interventional study is conducted at the General Surgery Department and the Diagnostic and Interventional Radiology Department, Sohag University Hospital. Eligible female patients aged 18 to 40 years with core needle biopsy-confirmed fibroadenomas (measuring 1.0 to 4.0 cm, classified as BI-RADS 2 or 3) are assigned to one of three parallel groups based on clinical indications, eligibility, and patient preference:
All participants will be monitored prospectively at scheduled postoperative intervals (1 week, 1 month, 3 months, 6 months, and 12 months). Baseline clinical, laboratory, and radiological data (including 3D lesion dimensions, volume calculation, and vascularity) are documented. The primary evaluation focuses on overall treatment success at 6 months, complemented by secondary evaluations of operative parameters, post-procedure pain scores, analgesic requirements, recovery time, adverse events, complete lesion resolution/volume reduction rates, recurrence, and subjective/objective cosmetic outcomes.
26 studies on the registry are indexed under Fibroadenoma; 6 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 20 interventional studies indexed under Fibroadenoma.
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Exclusion Criteria:
Patients undergo conservative management and reassurance comprising routine surveillance with clinical breast examination every 6 months and breast ultrasound every 6 to 12 months. Symptomatic medical treatment with simple analgesics or oral/topical NSAIDs (e.g., paracetamol or ibuprofen) is prescribed on an as-needed basis for mastalgia, without active surgical or ablative intervention.
Patients undergo ultrasound-guided percutaneous microwave ablation (MWA) under local anesthesia with hydrodissection protection (saline-lidocaine mixture) using a cooled-shaft microwave antenna to achieve complete coagulative necrosis of the fibroadenoma.
Procedure: Ultrasound-guided percutaneous microwave ablation
Patients undergo conventional open surgical excision of the fibroadenoma via periareolar or skin-crease incision under local anesthesia with sedation or general anesthesia, followed by meticulous layered subcuticular closure.
Procedure: Conventional open surgical excision
Percutaneous thermal ablation of the fibroadenoma was performed under continuous ultrasound guidance using a cooled-shaft microwave antenna following hydrodissection with 2% lidocaine and saline to protect the surrounding skin, nipple-areola complex, and pectoralis fascia.
Standard open surgical excision of the breast fibroadenoma performed en bloc with a minimal margin of normal breast tissue via periareolar or skin-crease incisions, followed by meticulous hemostasis and layered absorbable subcuticular wound closure.
Overall Treatment Success Rate
In the microwave ablation group, treatment success is defined as technically successful complete ablation with progressive reduction in lesion volume on ultrasound, absence of vascularity or tumor regrowth, and no need for secondary intervention. In the surgical excision group, it is defined as histologically confirmed complete lesion removal with no residual or recurrent mass and no reoperation. In the conservative group, success is defined as stability without symptom progression or crossover to intervention.
Time frame: 6 months post-procedure
Postoperative Pain Score
Assessed using the Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: At 24 hours, 1 week, and 1 month post-procedure
Lesion Volume Reduction Ratio
Calculated using ultrasound three-dimensional diameter measurements to assess the percentage of volume reduction in the microwave ablation group compared to baseline pre-procedure volume.
Time frame: At 1, 3, 6, and 12 months post-procedure
Cosmetic Outcome and Patient Satisfaction
Evaluated based on scar visibility, breast contour deformity, symmetry, and overall patient perception, graded as excellent, good, fair, or poor.
Time frame: 6 and 12 months post-procedure
Operative Duration
Measured in minutes from the beginning of the intervention (antenna insertion or incision) to the completion of hemostasis and wound dressing.
Time frame: Intraoperatively (during the procedure)
Post-procedure Complications Rate
Incidence of any intraoperative or postoperative adverse events, including bleeding, hematoma, skin burn, wound infection, seroma, or persistent pain.
Time frame: Up to 12 months post-procedure
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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