Introducing clinical protocol for ultrasound-guided high-intensity focused ultrasound ablation of uterine fibroids in patients in Europe, provided from experienced Chinese center-prospective comparative

Abstract

Introduction: This study aims to determine whether the Chinese clinical protocol, ultrasound guided high-intensity focused ultrasound (USgHIFU) combined with real-time monitoring using a contrast enhanced ultrasound (CEUS), also applies well in European patients with uterine fibroids. Methods: Seventy-five patients with 87 nodules of uterine fibroids from China and Bulgaria were treated with USgHIFU from April 2015 to July 2016, in the study. In Group A (Bulgarian) 26 (33 nodules) patients and in group B (Chinese) 49 (54 nodules) patients were included in the study. The same clinical procedure of USgHIFU treatment as well as a follow-up was performed on patients from China and Bulgaria. The general characteristics of the patients, the USgHIFU treatment and evaluation parameters, including; complications, fibroid size, tumor volume, subcutaneous fat size, non-perfused volume (NPV) and shrinkage process, were comparatively studied in Chinese and Bulgarian patients. Results: There were no significant differences in clinical parameters of Chinese and Bulgarian patients with uterine fibroids, such as vertical, left-right and аnterior-posterior size, treatment time, USgHIFU time.After USgHIFU treatment, no complications were recorded in both groups. On the 6 th and 12 th month after USgHIFU, fibroid nodules shrunk and the NPV was statistically significant compared to NPV before USgHIFU, but there were no statistically significant differences. Conclusions: The initial results of our study showed that CEUS clinical protocol for real time monitoring of efficacy and quality of the USgHIFU for uterine fibroid treatment that had been used in Chinese centers may also be applicable for European patients.