Department of Vascular Surgery, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China.
Department of Vascular Surgery, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China
BMJ Open. 2022 May 25;12(5):e059213. doi: 10.1136/bmjopen-2021-059213.
Endovenous microwave ablation (EMA) is a relatively novel thermal ablation treatment for great saphenous vein (GSV) varicosis, and its efficacy and safety are rarely reported. This study aims to explore whether EMA can be comparable to endovenous laser ablation (EVLA), which is a widely used thermal ablation treatment in clinical practice.
This is a multicentre, randomised controlled non-inferiority trial to compare the efficacy and safety of EMA and EVLA in patients with GSV varicosis. We will recruit 180 patients in 6 centres and randomly assign them into treatment group (EMA group) and control group (EVLA group) in a 1:1 ratio. The patients will return to the hospitals at 7 days, 3 months, 6 months and 12 months, and will be called at 1 month after the treatment for follow-up visits. The primary outcome is the occlusion rate of GSV immediately, at 6 months, and at 12 months after the treatment. The secondary outcomes are Venous Clinical Severity Score (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ) Score, operation time and instrument performance evaluation.
This protocol has been approved by the Clinical Trial Ethics Committee of Beijing Hospital (2020BJYYEC-126-02), Peking Union Medical College Hospital (KS2020393), Beijing Tsinghua Changgung Hospital (No.20279-2-02), Beijing Luhe Hospital.Capital Medical University (2020-LHYW-030-01), the First Hospital of Hebei Medical University (No.2020249), and the First Affiliated Hospital of Xi'an Jiaotong University (XJTU1AF2021LSY-12). The trial results will be published in peer-reviewed journals.
NCT04726124.
静脉内微波消融（EMA）是一种治疗大隐静脉曲张（GSV）的相对较新的热消融治疗方法，其疗效和安全性鲜有报道。本研究旨在探讨 EMA 是否可与临床广泛应用的热消融治疗方法——静脉内激光消融（EVLA）相媲美。
这是一项多中心、随机对照非劣效性试验，旨在比较 EMA 和 EVLA 治疗 GSV 静脉曲张患者的疗效和安全性。我们将在 6 家中心招募 180 名患者，并以 1:1 的比例将他们随机分配到治疗组（EMA 组）和对照组（EVLA 组）。患者将在治疗后 7 天、3 个月、6 个月和 12 个月返回医院，并在治疗后 1 个月进行随访。主要结局是治疗后即刻、6 个月和 12 个月 GSV 的闭塞率。次要结局是静脉临床严重程度评分（VCSS）、Aberdeen 静脉曲张问卷（AVVQ）评分、手术时间和仪器性能评估。
本方案已获得北京医院临床试验伦理委员会（2020BJYYEC-126-02）、北京协和医院（KS2020393）、北京清华长庚医院（No.20279-2-02）、首都医科大学北京潞河医院（2020-LHYW-030-01）、河北医科大学第一医院（No.2020249）和西安交通大学第一附属医院（XJTU1AF2021LSY-12）的批准。试验结果将发表在同行评议的期刊上。
NCT04726124。
