Efficacy and safety of endovenous microwave ablation versus laser ablation for great saphenous vein varicosis: study protocol for a multicentre, randomised controlled non-inferiority trial

• Published in: BMJ open 2022-05, Vol.12 (5), p.e059213-e059213
• Main Authors: Li, Yongjun, Wu, Weiwei, Li, Younan, Li, Jing, Sun, Mengnan
• Format: Article
• Language: English
• Subjects: Ablation; Cardiovascular Medicine; Clinical trials; Endovascular Procedures - adverse effects; Endovascular Procedures - methods; EPIDEMIOLOGY; Equivalence Trials as Topic; Humans; Laser Therapy - adverse effects; Laser Therapy - methods; Microwaves - therapeutic use; Multicenter Studies as Topic; Neoplasm Recurrence, Local - surgery; Protocols & guidelines; Randomized Controlled Trials as Topic; Saphenous Vein - surgery; Treatment Outcome; Varicose veins; Varicose Veins - surgery; Vascular medicine; Veins & arteries
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2021-059213

IntroductionEndovenous 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.Methods and analysisThis 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.Ethics and disseminationThis 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.Trial registration numberNCT04726124.