Treatment of Low-flow Venous Malformations With Electrosclerotherapy. Prospective Observational Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bleomycin.
- Who it may be relevant to
- Registry conditions: Vascular Malformations. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Trattamento Delle Malformazioni Venose a Basso Flusso Con l'Elettroscleroterapia. Studio Osservazionale Prospettico
Overview
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.
Interventions
- Drug Bleomycin
Using electroporation to infuse bleomycin in the lesion
Primary outcome measures
- Volume reduction in cm [Time frame: 1 year]
Secondary outcome measures (2)
- Reduction of pain (VAS score) [Time frame: 1 year]
- Improvement in quality of life ( EuroQol-5D questionnaire) [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Istituto Ortopedico Rizzoli — Bologna
Identifiers
NCT: NCT06189092 · CE AVEC: 639/2023/Oss/IOR