NCT06711120

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Chengdu University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Objective: To investigate the clinical efficacy of ultrasound-guided radiofrequency ablation and microwave ablation in the treatment of primary saphenous varicose veins.

Detailed description

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)

Conditions

• Varicose Veins of Lower Limb
• Venous Insufficiency of Leg
• Vascular Disease，Peripheral

Interventions

Type	Name	Description
PROCEDURE	Radiofrequency ablation and microwave ablation are used to treat small saphenous varicose veins, respectively	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.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-12-02
• Last updated: 2024-12-02

Locations

1 site across 1 country: China