About this trial
Objective: To investigate the clinical efficacy of ultrasound-guided radiofrequency ablation and microwave ablation in the treatment of primary saphenous varicose veins.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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).
Trial design
Parallel
Treatments tested in this trial
Radiofrequency ablation and microwave ablation are used to treat small saphenous varicose veins, respectively
Procedure/SurgeryDuring the procedure, 2% lidocaine was injected subcutaneously along the course of the saphenous vein under ultrasound guidance, and after local anaesthesia, an incision was made at the ankle joint of the saphenous vein to locate the saphenous vein, and a radiofrequency guidewire and catheter sheath were introduced.The saphenous vein was incised at the ankle joint under local anaesthesia. Under ultrasound monitoring, the radiofrequency catheter was placed in the saphenous popliteal vein at a distance of 1\~2 cm and the position of the catheter was fixed, and then anaesthesia and swelling fluid was injected into the fascial tissues around the main trunk of the small saphenous vein in segments.The two groups were treated with radiofrequency ablation and microwave ablation surgery, respectively.
Treatment groups
Trial outcomes
Primary outcomes
6-month postoperative occlusion rate
occlusion defined as no flow recirculation of the closed treated segment of the vein as confirmed by Doppler ultrasound
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