Comparative Analysis of Radiofrequency Ablation and Microwave Ablation Procedures for the Treatment of Small Saphenous Varicose Veins
Randomized Controlled Study of Radio Frequency and Microwave of the Small Saphenous Vein
Chengdu University of Traditional Chinese Medicine
150 participants
Dec 1, 2024
INTERVENTIONAL
Conditions
Summary
Objective: To investigate the clinical efficacy of ultrasound-guided radiofrequency ablation and microwave ablation in the treatment of primary saphenous varicose veins.
Eligibility
Inclusion Criteria6
- 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.
Exclusion Criteria13
- 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.
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Interventions
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.
Locations(1)
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NCT06711120