Randomized Controlled Study of Radio Frequency and Microwave of the Small Saphenous Vein
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 6-month postoperative occlusion rate
研究概览
简要总结
Objective: To investigate the clinical efficacy of ultrasound-guided radiofrequency ablation and microwave ablation in the treatment of primary saphenous varicose veins.
详细描述
Chronic venous insufficiency (CVI) is a common clinical disease, and varicose veins of the lower extremities are the main clinical manifestations of CVI, and studies have shown that the prevalence of CVI is 10%~25%.Although small saphenous varicose veins are rare, accounting for only 15% of great saphenous varicose veins, the surgical treatment of small saphenous varicose veins is more challenging due to the small saphenous varicose veins injected into the popliteal vein.In the late 19th and early 20th centuries, high ligation was the only treatment for the small saphenous varicose veins, however, it had a high recurrence rate and increased risk of nerve injury due to the presence of the small saphenous vein with the sural nerve. In open surgery for small saphenous varicose veins, about 26% of patients can be complicated by sural neuropathy, and due to changes in their anatomy, about 22% of patients do not adequately identify the proximal saphenous vein or saphenopopliteal fossa junction intraoperatively, even if the location is determined by ultrasound preoperatively.Since conventional surgery is more traumatic and has more complications, it is not favorable to the patient's postoperative recovery. In recent years, with the development of venous vascular ultrasound imaging technology, ultrasound-guided radiofrequency ablation and microwave ablation have gradually been widely used in the treatment of small saphenous varicose veins. Compared with conventional surgical procedures, radiofrequency ablation and microwave ablation are less invasive, safer and more effective for saphenous varicose veins, but not many studies have been conducted on the safety and efficacy of small saphenous varicose veins. Therefore, the aim of this study was to investigate the clinical efficacy of ultrasound-guided radiofrequency ablation versus microwave ablation in the treatment of primary small saphenous varicose veins.Translated with DeepL.com (free version)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years and ≤90 years;
- •Clinical diagnosis of primary varicose veins of the lower extremities, CEAP clinical classification C2-C6, requiring treatment of the great and/or small saphenous vein segments, and at least 1 of the clinical symptoms of swelling, pain, burning sensation, heaviness, easy fatigue, itchy skin, and night cramps;
- •Valve insufficiency of the great saphenous vein, small saphenous vein, or transport vein;
- •Doppler ultrasound confirmation of a saphenous vein diameter greater than 3 mm and less than 12 mm in the standing position;
- •Only one limb per patient was selected for inclusion in the study;
- •Patients signed an informed consent form and were willing to co-operate in completing the protocol-specified investigations and follow-up visits.
排除标准
- •Thrombosis of the great saphenous or small saphenous vein, or combined deep vein thrombosis, or previous history of deep vein thrombosis or pulmonary embolism.
- •Recurrent varicose veins after previous treatment.
- •Severe distortion of the great saphenous vein with anticipated catheter failure.
- •Severe lower limb ischaemia (CLI) (ABPI <0.8).
- •Known allergy to medications and device materials involved in the study.
- •Pre-existing implanted pacemaker, defibrillator, currently on regular anticoagulation therapy (e.g., warfarin, heparin).
- •Women who are pregnant or breastfeeding.
- •Unable or unwilling to complete the questionnaire.
- •Participating in a study of another drug or device.
- •Life expectancy <1 year.
- •Those undergoing treatment for skin malignancies other than non-melanoma.
- •Daily use of narcotic drugs or non-steroidal anti-inflammatory drugs to control pain due to venous disease.
- •In the judgement of the investigator, endovenous therapy is not appropriate.
结局指标
主要结局
6-month postoperative occlusion rate
时间窗: 6 months after surgery
occlusion defined as no flow recirculation of the closed treated segment of the vein as confirmed by Doppler ultrasound
次要结局
未报告次要终点
研究者
Chunshui He
chief physician
Chengdu University of Traditional Chinese Medicine