Vascular Malformation (VM)
Conditions
Interventions
Intervention group:Semiconductor laser combined with foam sclerotherapy
Control group:foam sclerotherapy
Sponsors
Shanghai Ninth Peoples Hospital,Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Age =18 and =70 years (inclusive), regardless of gender. 2.Diagnosis of complex trunk/extremity venous malformations (VMs) with clinical indications for intervention: maximum lesion diameter > 5 cm, with or without pain or functional impairment (e.g., limited joint mobility). 3.Lesions located in the upper or lower extremities (including the buttock and scapular regions). 4.Provision of written informed consent and willingness to comply with scheduled follow-up visits. 5.Anticipated survival > 24 months.
Exclusion criteria
Exclusion criteria: 1.High-flow VMs (AVF confirmed by DSA/US); 2.High-risk anatomy: Infiltrative lesions encasing nerves (>180°) or major arteries (uncontrollable thermal risk); 3.Superficial depth: Lesions 1.5, or ongoing anticoagulation; 5.Severe organ dysfunction: CKD =4 or NYHA =III; 6.Pregnancy, lactation, or allergy to sclerosants (lauromacrogol/bleomycin);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Efficacy Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Lesion volume reduction rate and recurrence rate; | — |
Countries
China
Contacts
Public ContactRuihua Wang
Shanghai Ninth Peoples Hospital,Shanghai JiaoTong University School of Medicine
Outcome results
None listed