High Intensity Focused Ultrasound Treatment Of Uterine Fibroids Safetyof Imaging Atudy

BackgroundHigh Intensity Focused Ultrasound (HIFU) rose in the 1980s, and currently developed extensively and rapidly in the United States, Britain, Japan and China. High-intensity ultrasound gather in vivo target area using it's good penetrability,directionality and focalization,and transiently create 60~100℃h igh temperature in focus localization.Without the temperature of organizations outside focus localization upgraded.Hence,HIFU could kill cells in target area accurately. Currently,the research about HIFU treatment has been widely used for treatment of malignant tumors clinical treatment such as liver cancer, malignant bone tumors, breast cancer, soft tissue tumors. With minimally invasive surgery and imaging technology development, the application of HIFU technology in the benign tumors such as uterine leiomyomas will form hot spot. Domestic and foreign scholars have done a lot experiments in vitro and in vivo, demonstrating the effectiveness and feasibility of HIFU treatment on uterine leiomyomas. Thus, HIFU technology has been effectively applied to the current clinical treatment of uterine leiomyomas. The biological effects (mainly thermal effects) are generated after HIFU ultrasound beam penetrates into the body,and physical effects such as reflection, scattering are created when ultrasound contact the organizations of the interface.HIFU treatment of uterine leiomyomas may damage normal tissues or organs in the surrounding or in sound path.On the basis of HIFU treatment uterine leiomyomas in vitro and in vivo,this study aimed to investigate the safety of HIFU treatment on uterine leiomyomas using imaging technology.ObjectiveTo investigate the impacts of HIFU treatment on ovaries and sound channels tissues or organs by observing their imaging changes before and after HIFU treating uterine leiomyomas and analyze postoperative adverse of patients for providing more valuable information for clinical treatment.Materials and methods1 Study subject: HIFU treatment of uterine leiomyomas patients.2 HIFU treatment: JC-focused ultrasound tumor therapeutic system was used. The parameters of therapeutic transducer were: frequency-0.9 MHz, focal length-150mm. Patients prone in HIFU treatment bed, then uterine leiomyomas was targeted. According to fibroid size and location, HIFU treatment parameters were set, then uterine leiomyomas were subjected to ultrasound-guided therapy.The HIFU scanning was from point to line to plane and from deep to shallow layers . 3 Research and observation indicators:3.1 The impacts of HIFU treatment on ovaries:1) Observing the sonogram characteristics changes of uterine leiomyomas and ovaries, and the hemodynamics changes of ovarian artery using color Doppler ultrasound before and after (immediately,1month,3month) HIFU treatment.The gray value of ovaries and leiomyomas were measured by gray-processing software; 2) The patient's menstrual cycle, menstruation, menstrual volume changes were observed before and after HIFU treatment, The low estrogen-related symptoms of patients were observed after HIFU treatment; 3) The ovarian hormones of selected patients were assessed prior to and post operation.3.2 The impacts of HIFU treatment on sound path: 1) The sonogram changes of the major tissue or organs (abdominal wall, endometriosis, bladder wall) in sound path were observed using color Doppler ultrasound before and after HIFU treatment; 2) The MRI signal changes of f leiomyomas, sacrum and rectal were observed using magnetic resonance imaging before and after( after 1month or immediately) HIFU treatment, and their MRI signal value were measured using MRI signal processing software; 3) The related factors for the skin damage, fat layer damage and sacrum injury were analyzed.3.3 The adverse reactions of HIFU treating uterine leiomyomas: 1) During HIFU treatment, vital signs, oxygen saturation, ECG monitoring and the operating reaction of patients were observed,After HIFU treatment, the vital signs, skin lesions, vaginal bleeding, abdominal pain , sacrococcygeal pain and other adverse reactions of patients were observed;2) The corresponding imaging features of postoperative adverse reactions were analyzed; 3) The relevance of the operative reaction and the corresponding injury were analyzed.Result1 The 2D ultrasound showed that the overall gray increased or a massive echo enhanced within leiomyomas after HIFU treatment,The color Doppler showed that the blood flowing signals within leiomyomas mostly disappeared and leiomyomas peripheral blood flow decreased significantly or disappeared after HIFU treatment; MRI showed that fibroids are coagulation necrosis, MRI enhanced scan showed that all or most of fibroids have no enhancement after treatment; With the volume of leiomyomas gradually diminished; After three-month follow-up shrinking rate of leiomyomas volume was about 30%～65%.2 The ovarian sonogram characteristics have no significant changes before and after HIFU treatment; No significant difference of the ovarian arteries hemodynamic parameters and ovarian hormones were found before and after HIFU treatment; The menstruation of patients improved after treatment,The menstrual blood volume was significantly reduced aftertreatment(P<0.05); No patients presented low estrogen symptoms after treatment.3 No changes were found in the sonogram of patients'abdominal wall, uterine endomembrane, bladder wall before and after HIFU treatment;.Individual patients abdominal wall skin or fat were damaged, The skin of patients were damaged using water sac during HIFU treatment(P<0.05), more treatment may induce easily fatty layer injury (P<0.05). After HIFU treatment MRI showed that some patients'sacrum appear abnormal signals that increased in T2 weighted imaging (T2WI), and degraded in T1 weighted imaging (T1WI); sacrum abnormal signals might occur when the distance of leiomyomas to the sacrum was less than 30mm (P<0.05). Long-time HIFU radiation and high treatment energy also may induce sacrum abnormal signals (P<0.05); MRI showed no significant change in rectum wall MRI signals before and after the treatment.4 After HIFU treatment, the vital signs, oxygen saturation and ECG monitoring of patients had no unusual circumstances. The reaction of patients is mainly pain in therapy area, skin singe and sacrococcygeal pain and so on, Tthe correlations between skin singe and skin damage were not statistically significant (P>0.05), Also the correlations of pain in therapy area with abdominal wall damage were not significant (P>0.05), Nevertheless, the correlations of sacrococcygeal sacral pain with sacrum injury were significant (P <0.05). After HIFU treatment, adverse reactions of patients were major abdominal pain, skin damage, vaginal bleeding, sacrococcygeal pain, lower extremity sensory abnormality, re-level and so on. They had minimal or no impacts on patients. However, they didn't affect quality of life in patients.ConclusionHIFU treatment is a feasible and safeapproach to uterine leiomyomas treatment;The imaging technology can effectively evaluate the security of HIFU treatment; HIFU treatment had no effect on ovaries of patients; HIFU treatment had no effect on the majority of tissue or organ in sound path It only induce abdominal wall(skin or fat)damage in individual patients, and may cause MRI abnormal signal in sacrum for some patients.After treatment, adverse reactions were mainly abdominal pain, skin damage, vaginal bleeding, sacrococcygeal pain,which had minimal or no impacts on patients, without affecting quality of life.in patients .HIFU technique is a minimally invasive or non-invasive treatment, and it's clinical application will be a broad prospect.