目的:将高强度聚焦超声(HIFU)的强度增加30%治疗直肠子宫内膜异位症是一种安全的方法吗?
结论:这项研究表明,将HIFU的强度增加30%治疗直肠子宫内膜异位症是安全的,总体上没有Clavien-DindoIII级并发症,也就是没有直肠阴道瘘。
背景:一项包括20例直肠子宫内膜异位症患者的可行性研究表明,无严重并发症,消化系统疾病的显著改善,痛经,性交困难,和健康状况,尽管子宫内膜异位症结节的体积似乎没有减少。
方法:一项前瞻性多中心队列研究于2020年至2022年进行,纳入60例症状性直肠子宫内膜异位症患者。在医疗失败之后,提供HIFU治疗作为手术的替代方案。
方法:由于本研究的主要目的是检查安全性,根据美国国家癌症研究所不良事件通用术语标准(CTCAE)和Clavien-Dindo分类,对随访6个月期间观察到的所有不良事件进行分析和分级.次要目标包括使用经过验证的问卷评估症状的演变:具有视觉模拟量表的妇科和消化系统疼痛症状,医疗结果研究36项简表(SF-36)问卷的健康状况,术后平均每日疼痛水平,和治疗后10天内需要的镇痛药物。在第1天也进行MRI以检测早期并发症。最后,我们在治疗后6个月对结节的演变进行了盲法MRI回顾.
结果:30%的患者在脊髓麻醉下进行手术。治疗的中位持续时间为32分钟。55名患者在第一天离开了医院。在第1天进行的MRI扫描未显示任何早发性术后并发症。使用Clavien-Dindo分类,我们列出了56.7%的一级事件,3.4%二级赛事,没有III级或更高的事件。在1、3和6个月时,所有的妇科,消化和一般症状,以及健康状况,有了显著的改善。结节的演变也是显著的(P<0.001),体积减少28%。
结论:主要目标是安全性而非有效性。该研究不是随机的,也没有对照组。
结论:HIFU治疗直肠子宫内膜异位症可改善症状,发病率低;对于选定的患者,在药物治疗失败后,这可能是一种有价值的替代手术方法。
背景:该研究由EDAPTMS公司资助。Dubernard和Rousset教授是EDAPTMS的顾问。Dubernard从EDAP-TMS获得了旅行支持。F.Chavrier博士获得了EDAP-TMS的工业资助。他开发了一种用于产生聚焦超声波的装置,减少了治疗时间。该设备已获得EDAP-TMS的专利。Lafon博士获得了EDAP-TMS的工业资助;他宣称EDAP-TMS直接向INSERM提供资金,以支持年轻的超声治疗研究主席,这与当前的研究无关。
背景:ClinicalTrials.gov标识符NCT04494568。
OBJECTIVE: Is increasing the intensity of high-intensity focused ultrasound (HIFU) by 30% in the treatment of rectal endometriosis a safe procedure?
CONCLUSIONS: This study demonstrates the safety of a 30% increase in the intensity of HIFU in the treatment of rectal endometriosis, with no Clavien-Dindo Grade III complications overall, and namely no rectovaginal fistulae.
BACKGROUND: A feasibility study including 20 patients with rectal endometriosis demonstrated, with no severe complications, a significant improvement in digestive disorders, dysmenorrhoea, dyspareunia, and health status, although the volume of the endometriosis nodule did not appear to be reduced.
METHODS: A prospective multicentre cohort study was conducted between 2020 and 2022 with 60 patients with symptomatic rectal endometriosis. Following the failure of medical treatment, HIFU treatment was offered as an alternative to surgery.
METHODS: As the main objective of this study was to examine safety, all adverse events observed during the 6 months of follow-up were analysed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) and Clavien-Dindo classifications. Secondary objectives included evaluating the evolution of symptoms using validated questionnaires: gynaecological and digestive pain symptoms with a visual analogue scale, health status with the Medical Outcomes Study 36-item Short Form (SF-36) questionnaire, average post-operative daily pain level, and analgesic medication required in the 10 days following treatment. MRI was also performed at Day 1 to detect early complications. Finally, we performed a blinded MRI review of the evolution of the nodule at 6 months post-treatment.
RESULTS: The procedure was performed under spinal anaesthesia for 30% of the patients. The median duration of treatment was 32 min. Fifty-five patients left the hospital on Day 1. MRI scans performed on Day 1 did not highlight any early-onset post-operative complication. Using the Clavien-Dindo classification, we listed 56.7% Grade I events, 3.4% Grade II events, and no events Grade III or higher. At 1, 3, and 6 months, all gynaecologic, digestive and general symptoms, as well as health status, had significantly improved. The evolution of the nodule was also significant (P < 0.001) with a 28% decrease in volume.
CONCLUSIONS: The main objective was safety and not effectiveness. The study was not randomized and there was no control group.
CONCLUSIONS: HIFU treatment for rectal endometriosis results in an improvement of symptoms with low morbidity; as such, for selected patients, it could be a valuable alternative to surgical approaches following the failure of medical treatment.
BACKGROUND: The study was funded by the company EDAP TMS. Professors Dubernard and Rousset are consultants for EDAP TMS. Dubernard received travel support from EDAP-TMS. Dr F. Chavrier received industrial grants from EDAP-TMS. He has developed a device for generating focused ultrasonic waves with reduced treatment time. This device has been patented by EDAP-TMS. Dr Lafon received industrial grants from EDAP-TMS; he declares that EDAP-TMS provided funding directly to INSERM to support a young researcher chair in therapeutic ultrasound, which is unrelated to the current study.
BACKGROUND: ClinicalTrials.gov identifier NCT04494568.