RecruitingNCT06189092

Treatment of Low-flow Venous Malformations With Electrosclerotherapy. Prospective Observational Study

Trattamento Delle Malformazioni Venose a Basso Flusso Con l'Elettroscleroterapia. Studio Osservazionale Prospettico

Sponsor

Istituto Ortopedico Rizzoli

Enrollment

65 participants

Start Date

Oct 28, 2023

Study Type

OBSERVATIONAL

Conditions

Vascular Malformations

Summary

Venous malformations (MVs) are congenital abnormalities of the central or periphery caused by developmental errors at different stages of embryogenesis. Histologically they are characterized by large, venous-like vascular spaces. Scleroembolization constitutes the most widespread method in the treatment of venous malformations allowing good results with low invasiveness. Currently, Bleomycin (and its derivatives) is among the most widely used sclerosing agents for slow-flowing vascular malformations (venous and lymphatic malformations) because of the low rate of local serious adverse events such as swelling, necrosis, and nerve injury compared with others.

Eligibility

Min Age: 16 Years

Inclusion Criteria3

Diagnosis of low-flow venous malformations eligible for electrosclerotherapy
Non-indication for embolizing treatment
Previous treatments are not an exclusion factor, provided that at least 30 days have elapsed.

Exclusion Criteria10

Previous treatment for \< 30 days
Pregnancy and lactation status
Patients of childbearing age without contraceptive use
Presence of metal synthetic media
COPD with FiO2 \< 30 mmHg
Impaired renal function with eGFR\<30 ml/min/1.73mq
Patients with Bleomycin intolerance or previous episodes of toxicity Bleomycin-related
Patients who have already received a cumulative dose of Bleomycin ≥100 mg
Patients who have undergone prior thoracic radiotherapy
Patients with a history of seizures and epilepsy

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