Comparative Efficacy of Ultrasound-Guided Radiofrequency Ablation versus Sclerotherapy for Venous Malformations: A Randomized Controlled Trial

Venous malformations (VMs) are congenital, low-flow vascular anomalies that commonly present with pain, swelling, cosmetic concerns, and functional impairment. Sclerotherapy is the current standard minimally invasive treatment, but multiple sessions are often required and treatment response may be variable. Radiofrequency ablation (RFA) is an emerging image-guided thermal technique that may offer more effective lesion devascularization with fewer sessions.

This randomized, active-controlled, interventional trial aims to compare the efficacy and safety of ultrasound-guided RFA versus sclerotherapy in patients with slow-flow venous malformations. Eligible participants will be randomized into two parallel groups: one undergoing RFA and the other receiving standard sclerotherapy. The primary outcome is percentage reduction in VM volume on imaging at 6 months. Secondary outcomes include improvement in pain, symptom relief, and procedure-related complications.

The study is intended to generate comparative evidence to determine whether RFA provides superior or equivalent clinical outcomes to sclerotherapy in the management of slow-flow venous malformations, thereby guiding future therapeutic decision-making.