Ultrasound-Guided Emulsification Therapy in the Clinical Treatment of Benign Breast Nodules
Ultrasound-Guided Emulsification Therapy for Benign Breast Nodules: A Clinical Study
Background： Benign breast nodules are common breast diseases in women, including fibroadenomas, hyperplastic nodules, and other benign lesions. Traditionally, open surgical excision has been the standard treatment, but it is associated with visible scarring, damage to breast shape, prolonged recovery, and high costs. While minimally invasive approaches such as vacuum-assisted excision and thermal ablation (radiofrequency, microwave, laser) have been developed, they still have limitations including intraoperative bleeding, residual lesions, skin injury, and postoperative pain. Ultrasound-guided emulsification therapy is an emerging minimally invasive technique that utilizes ultrasonic energy to emulsify nodule tissue followed by aspiration, offering potential advantages of precise tissue targeting, minimal damage to surrounding normal breast tissue, favorable cosmetic outcomes, and rapid recovery. However, its clinical safety and efficacy in the treatment of benign breast nodules remain to be systematically evaluated.
Study Objective： This study aims to investigate the safety and efficacy of ultrasound-guided emulsification therapy in the minimally invasive treatment of benign breast nodules.
Study Methods： This is a single-center, prospective clinical study. A total of 30 eligible patients with clinically and pathologically confirmed benign breast nodules scheduled for treatment will be enrolled. All participants will undergo ultrasound-guided emulsification therapy. The primary outcome measure is the nodule clearance rate (complete disappearance rate assessed by postoperative ultrasound). Secondary outcome measures include operation time, intraoperative blood loss, postoperative pain score (VAS), complication rate, recurrence rate at follow-up, cosmetic outcome assessment, and patient satisfaction. Patients will be followed up for 6 months after treatment.
Study Significance： The results of this study will provide evidence-based clinical support for the application of ultrasound-guided emulsification therapy in the minimally invasive treatment of benign breast nodules, and may help optimize treatment strategies, preserve breast shape and aesthetics, and improve patient outcomes and quality of life.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
New Technology： Ultrasound-guided emulsification therapy is an emerging minimally invasive technique that, under real-time ultrasound guidance, utilizes ultrasonic energy to emulsify benign breast nodule tissue, followed by immediate aspiration of the emulsified tissue through a small puncture channel. Compared with conventional open surgical excision, vacuum-assisted excision, and thermal ablation (radiofrequency, microwave, or laser), ultrasound-guided emulsification therapy offers the advantages of real-time intraoperative ultrasound monitoring, precise nodule targeting, minimal damage to surrounding normal breast parenchyma and ducts, effective fragmentation and clearance of nodule tissue, good intraoperative hemostasis, no thermal injury to the skin or nipple-areola complex, the ability to operate through a tiny puncture point, favorable cosmetic outcomes, preservation of breast shape, and rapid postoperative recovery. However, its clinical safety and efficacy in the minimally invasive treatment of benign breast nodules remain to be systematically validated.
Sample Size Calculation (30 cases)：
This is a single-center, prospective, single-arm clinical study with the primary outcome of nodule clearance rate after ultrasound-guided emulsification therapy for benign breast nodules. According to previous literature, the complete clearance rate of conventional open surgical excision is approximately 95%-100%, while vacuum-assisted excision achieves a complete clearance rate of 85%-95% and thermal ablation reports a complete ablation rate of 80%-95% for benign breast nodules. This study assumes that the nodule clearance rate of ultrasound-guided emulsification therapy is no less than 90%. With a two-sided significance level α = 0.05 and a margin of error d = 10%, the sample size is calculated using the binomial distribution formula:
n = Z²α/2 × p(1-p) / d² Substituting p = 0.90, Zα/2 = 1.96, and d = 0.10 yields n ≈ 34.6. Accounting for an approximate 10% loss to follow-up, a total of 30 patients will be enrolled. In addition, as an exploratory study, a sample size of 30 is sufficient to assess the safety and preliminary efficacy of ultrasound-guided emulsification therapy and is comparable to the sample sizes of similar minimally invasive breast studies (20-40 cases) reported in the literature.
Statistical Analysis Methods： Analysis sets: The full analysis set (FAS), including all patients who received ultrasound-guided emulsification therapy and completed at least one postoperative assessment, will be used for efficacy analysis. The safety set (SS), including all patients who received ultrasound-guided emulsification therapy, will be used for safety analysis.
Descriptive statistics: Normally distributed continuous variables are presented as mean ± standard deviation (x̄ ± s); non-normally distributed continuous variables are presented as median (interquartile range) [M (P25, P75)]; categorical variables are presented as frequency (percentage) [n (%)].
Primary outcome analysis: The nodule clearance rate is presented as a point estimate with a 95% confidence interval (95% CI), calculated using the binomial distribution method.
Secondary outcome analysis: Continuous variables such as operation time, intraoperative blood loss, and postoperative pain score (VAS) are analyzed using descriptive statistics; categorical variables such as complication rate and recurrence rate are presented as frequency (percentage) with 95% CI.
Survival analysis: The postoperative recurrence-free survival rate is analyzed using the Kaplan-Meier method, and survival curves are plotted.
Statistical software and significance level: Statistical analysis is performed using SPSS 26.0 (IBM Corp., Armonk, NY, USA) or R 4.x software. All tests are two-sided, and P < 0.05 is considered statistically significant.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yukun Luo, Doctor
- Phone Number: 010-66937394 +86 133 1137 3556
- Email: lyk301@163.com
Study Contact Backup
- Name: Mingbo Zhang, Doctor
- Phone Number: 010-66937394 +86 135 5274 4805
- Email: owsifanduizhe@126.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
1. Female aged 18 to 60 years; 2. Breast ultrasound indicating BI-RADS category 3; 3. Benign nodule confirmed by ultrasound-guided core needle biopsy pathology; 4. Maximum diameter of the nodule greater than 1 cm; 5. Ultrasound showing well-defined nodule borders with a distance of ≥ 0.5 cm from the skin, pectoralis major muscle, and major lactiferous ducts; 6. Patients with explicit demand for minimally invasive and cosmetic treatment, voluntarily accepting this new technology; 7. Able to understand the study content, voluntarily participate in the study and sign the informed consent form; 8. Willing and able to cooperate with preoperative examinations, intraoperative procedures, and regular postoperative follow-up.
-
Exclusion Criteria:
- Coagulation dysfunction (platelet count < 80×10⁹/L, PT prolongation > 3 s, APTT prolongation > 10 s) or currently receiving anticoagulant therapy (aspirin, warfarin, clopidogrel, etc.);
- Malignant or suspiciously malignant findings on core needle biopsy pathology;
- BI-RADS category 4 or above;
- Coarse calcification within the nodule (low efficiency of ultrasonic emulsification);
- Pregnant or lactating women;
- Nodule located directly beneath the nipple or closely adjacent to the opening of major lactiferous ducts;
- Severe dysfunction of vital organs such as the heart, liver, or kidney;
- Severe mental illness or cognitive impairment that prevents cooperation with the procedure and follow-up;
- Previous history of ipsilateral breast surgery or radiotherapy;
- Currently participating in other clinical studies of drugs or medical devices. -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CUSA Group
All enrolled patients with clinically and pathologically confirmed benign breast nodules will undergo ultrasound-guided emulsification therapy through a tiny puncture channel under real-time ultrasound monitoring.
|
CUSA Minimally Invasive Resection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complete resection rate of benign breast nodules
Time Frame: Within 1 week after surgery
|
Proportion of patients with complete resection of benign breast nodules confirmed by postoperative ultrasound or pathological examination.
|
Within 1 week after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yukun Luo, Chinese PLA General Hospital
Publications and helpful links
General Publications
- Stachs A, Stubert J, Reimer T, Hartmann S. Benign Breast Disease in Women. Dtsch Arztebl Int. 2019 Aug 9;116(33-34):565-574. doi: 10.3238/arztebl.2019.0565.
- Ward RC, Lourenco AP, Mainiero MB. Ultrasound-Guided Breast Cancer Cryoablation. AJR Am J Roentgenol. 2019 Sep;213(3):716-722. doi: 10.2214/AJR.19.21329. Epub 2019 May 23.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- S2026-633-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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