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

Recruiting

• Conditions: Vascular Malformations
• Interventions: Drug: Bleomycin

• Registration Number: NCT06189092
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-28
• Study First Submitted: 2023-11-30
• Study First Submitted QC: 2023-12-19
• Study First Posted: 2024-01-03
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-25
• Last Update Posted: 2024-10-29
• Primary Completion: 2026-11-28
• Study Completion: 2027-11-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Performed electrosclerotherapy	Bleomycin	All patients who performed electrosclerotherapy in the treatment of vascular malformations

Primary Outcome Measures

Name	Time	Method
Volume reduction in cm	1 year	Reduction of the lesion of at least 30% evaluated with MRI, measuring the diameter of the lesion in cm.

Secondary Outcome Measures

Name	Time	Method
Reduction of pain (VAS score)	1 year	Clinical assessment regarding pain by Visual Analogue Scale (VAS) score (0-100 mm), in which 0 represents no pain, and 100 represents maximum pain imaginable.
Improvement in quality of life ( EuroQol-5D questionnaire)	1 year	Clinical assessment regarding quality of life by EuroQol-5D questionnaire. EQ-5D score can range from -0.594 to 1.0.; The minimum value represents the worst possible health condition. The maximum value of 1.0 represents the best possible health condition. A value of 1.0 indicates that the patient has no problem in any of the five dimensions assessed by the questionnaire.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Emilia Romagna, Italy