Pilot study: safety and effectiveness of simple ultrasound-guided high-intensity focused ultrasound ablating uterine leiomyoma with a diameter greater than 10 cm.

OBJECTIVE: The study aimed to prospectively investigate whether uterine leiomyoma greater than 10 cm in diameter could be treated with simple ultrasound-guided high-intensity focused ultrasound (USgHIFU) in one-time treatment.

METHODS: A total of 36 patients with 36 symptomatic uterine leiomyoma greater than 10 cm in diameter who underwent simple USgHIFU treatment alone were analysed. Enhanced MRI was performed before and after HIFU treatment, and all patients had follow-up for 6 months after treatment. Symptom severity scores, treatment time, treatment speed, ablation rate, energy effect ratio, uterine leiomyoma regression rate, adverse events, liver and kidney functions, coagulation function and routine blood count were included in the study endpoints.

RESULTS: The mean diameter of uterine leiomyoma was 11.2 ± 1.3 cm (10.0-14.3 cm). The median treatment time and treatment speed were 104.0 min (90.0-140.0 min) and 118.8 cm3  h-1  (86.2-247.1 cm3  h-1 ), respectively. The ablation rate of uterine leiomyoma was 71.9 ± 20.4% (32.1-100.0%), and the regression rate of uterine leiomyoma was 40.8 ± 7.5% (25.6-59.9%) at 6 months after treatment. The mean symptom severity scores decreased by an average of approximately 8.6 ± 2.3 (5-14) points. There were no significant changes in haemogram and blood chemical indexes of patients, except for the transient elevation of aspartate aminotransferase, total bilirubin and white blood cells after treatment. No serious adverse reactions occurred.

CONCLUSION: According to our preliminary results, simple USgHIFU is a safe and effective single-treatment method of treating uterine leiomyoma greater than 10 cm in diameter and is an almost innocuous alternative therapeutic strategy. Advances in knowledge: The conclusions indicate simple USgHIFU is safe and effective as one-time treatment of uterine leiomyoma greater than 10 cm in diameter, it could be a promising therapeutic strategy.