Ultrasound-Guided Emulsification Therapy in the Clinical Treatment of Benign Breast Nodules

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.