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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Performed electrosclerotherapy | All patients who performed electrosclerotherapy in the treatment of vascular malformations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bleomycin | Drug | Using electroporation to infuse bleomycin in the lesion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Volume reduction in cm | Reduction of the lesion of at least 30% evaluated with MRI, measuring the diameter of the lesion in cm. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of pain (VAS score) | 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. | 1 year |
| Improvement in quality of life ( EuroQol-5D questionnaire) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients affected by low-flow vascular malformations
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Recruiting | Bologna | Emilia-Romagna | 40136 | Italy |
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| ID | Term |
|---|---|
| D054079 | Vascular Malformations |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D001761 | Bleomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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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. |
| 1 year |
| D000602 |
| Amino Acids, Peptides, and Proteins |