FibroadenomaNCT07890766
Management of Breast Fibroadenoma: Comparing Observation, Microwave Ablation, and Surgical Excision
A study testing Ultrasound-guided percutaneous microwave ablation and Conventional open surgical excision in people with Fibroadenoma and Breast Fibroadenoma, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Fibroadenoma, Breast Fibroadenoma, Benign Breast Disease
- What is being tested?
- Ultrasound-guided percutaneous microwave ablation and Conventional open surgical excision
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sohag University Hospital
Sohag
Ahmed Abdelhameed, M.B.B.Ch., +201146870191, Ahmed.Asem@med.sohag.edu.eg
Ahmed Abdelhameed, M.B.B.Ch.
About this study
Official title: Management of Breast Fibroadenoma; Multidisciplinary Approach: A Comparative Interventional Study Evaluating Conservative Management, Ultrasound-Guided Microwave Ablation, and Conventional Surgical Excision
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.
Read the detailed description
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:
- Conservative Management Group (Observation): Patients undergo routine surveillance consisting of periodic clinical breast examinations and ultrasonography (every 6 to 12 months), along with symptomatic medical treatment (simple analgesics/NSAIDs) when mild mastalgia is present.
- Microwave Ablation Group (MWA): Patients undergo ultrasound-guided percutaneous microwave ablation using a cooled-shaft microwave antenna under local anesthesia with hydrodissection (lidocaine-saline mixture) to insulate the skin, nipple-areola complex, and pectoralis fascia from thermal injury.
- Surgical Excision Group: Patients undergo conventional open surgical excision via periareolar or skin-crease incisions under local sedation or general anesthesia, with meticulous layered absorbable subcuticular closure.
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.
- Conditions
- Fibroadenoma, Breast Fibroadenoma, Benign Breast Disease
- Being tested
- Ultrasound-guided percutaneous microwave ablation, Conventional open surgical excision
- Keywords
- Microwave Ablation, Surgical Excision, Conservative Treatment, Ultrasound-Guided, Benign Breast Neoplasm
- Medical subject headings
- Fibroadenoma, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided percutaneous microwave ablationProcedure or surgery
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.
Conventional open surgical excisionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Conservative Management (Observation) | No intervention | 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. |
| Microwave Ablation Group (MWA) | Experimental | 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. Receives: Procedure: Ultrasound-guided percutaneous microwave ablation |
| Surgical Excision Group | Active comparator | 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. Receives: Procedure: Conventional open surgical excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months post-procedure
Secondary outcomes (5)
Postoperative Pain Score
Assessed using the Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibroadenomaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm parallel comparative interventional study comparing conservative management (observation), ultrasound-guided microwave ablation, and open surgical excision.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Asem Abdelhameed, Sohag University
- Investigators
- Ahmed Abdelhameed, M.B.B.Ch., Study director, Faculty of Medicine, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890766
- Sponsor's protocol ID
- SURG-BREAST-MWA-2026
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Breast Fibroadenoma; Multidisciplinary Approach: A Comparative Interventional Study Evaluating Conservative Management, Ultrasound-Guided Microwave Ablation, and Conventional Surgical Excision
- ClinicalTrials.gov ID
- NCT07890766
- Acronym / sponsor ID
- SURG-BREAST-MWA-2026
- Conditions
- Fibroadenoma, Breast Fibroadenoma, Benign Breast Disease
- Keywords
- Microwave Ablation, Surgical Excision, Conservative Treatment, Ultrasound-Guided, Benign Breast Neoplasm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Conservative Management Group (Observation): Patients undergo routine surveillance consisting of periodic clinical breast examinations and ultrasonography (every 6 to 12 months), along with symptomatic medical treatment (simple analgesics/NSAIDs) when mild mastalgia is present.
- Microwave Ablation Group (MWA): Patients undergo ultrasound-guided percutaneous microwave ablation using a cooled-shaft microwave antenna under local anesthesia with hydrodissection (lidocaine-saline mixture) to insulate the skin, nipple-areola complex, and pectoralis fascia from thermal injury.
- Surgical Excision Group: Patients undergo conventional open surgical excision via periareolar or skin-crease incisions under local sedation or general anesthesia, with meticulous layered absorbable subcuticular closure.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three-arm parallel comparative interventional study comparing conservative management (observation), ultrasound-guided microwave ablation, and open surgical excision.
| Arm | Type | Receives |
|---|---|---|
| Conservative Management (Observation) | No intervention | –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. |
| Microwave Ablation Group (MWA) | Experimental | Procedure: Ultrasound-guided percutaneous microwave ablationPatients 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. |
| Surgical Excision Group | Active comparator | Procedure: Conventional open surgical excisionPatients 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-guided percutaneous microwave ablationPercutaneous 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. | Procedure or surgery | Microwave Ablation Group (MWA) |
| Conventional open surgical excisionStandard 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. | Procedure or surgery | Surgical Excision Group |
Primary outcome
Overall Treatment Success Rate
Time frame: 6 months post-procedure
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.
5 secondary outcomes
Postoperative Pain Score
Time frame: At 24 hours, 1 week, and 1 month post-procedure
Lesion Volume Reduction Ratio
Time frame: At 1, 3, 6, and 12 months post-procedure
Cosmetic Outcome and Patient Satisfaction
Time frame: 6 and 12 months post-procedure
Operative Duration
Time frame: Intraoperatively (during the procedure)
Post-procedure Complications Rate
Time frame: Up to 12 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmed Abdelhameed, M.B.B.Ch. study director
Faculty of Medicine, Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided percutaneous microwave ablation and Conventional open surgical excision in people with Fibroadenoma and Breast Fibroadenoma, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Asem Abdelhameed, M.B.B.Ch. (+201146870191, Ahmed.Asem@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Treatment Success Rate (time frame: 6 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.