Comparative Analysis of Radiofrequency Ablation and Microwave Ablation Procedures for the Treatment of Small Saphenous Varicose Veins

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorChengdu University of Traditional Chinese Medicine

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Radiofrequency ablation and microwave ablation are used to treat small saphenous varicose veins, respectively

    Procedure/Surgery

    During 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

150 Participants
are divided into 2 treatment groups
Group A: Radiofrequency ablation for the treatment of varicose veins of the small saphenous veinExperimental treatment 1 intervention
Group B: Microwave ablation for the treatment of varicose veins of the small saphenous veinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

6-month postoperative occlusion rate

occlusion defined as no flow recirculation of the closed treated segment of the vein as confirmed by Doppler ultrasound

Time frame
6 months after surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

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