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

Istituto Ortopedico Rizzoli

Status: Enrolling

Conditions: Vascular Malformations

Treatments: Drug: Bleomycin

Study type: Observational

Funder types: Other

Identifiers

NCT06189092

CE AVEC: 639/2023/Oss/IOR

Details and patient eligibility

About

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.

Enrollment: 65 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

65 participants in 1 patient group

Performed electrosclerotherapy

Description:

All patients who performed electrosclerotherapy in the treatment of vascular malformations

Treatment:

Drug: Bleomycin