Bleomycin Electrosclerotherapy (BEST) for Slow-flow Vascular Malformations
Slow-flow vascular malformations consist of abnormally formed veins, capillaries, lymphatic vessels, or a combination of these. They can cause pain, swelling, functional limitations, and concerns about appearance and may substantially affect quality of life. Bleomycin electrosclerotherapy (BEST) is an emerging treatment in which the sclerosant bleomycin is injected into the malformation and brief electrical pulses are applied to increase its local effect.
As treatment of slow-flow vascular malformations primarily aims to alleviate symptoms and improve quality of life, patient-reported outcomes are central to assessing treatment benefit. However, the available evidence on patient-reported outcomes following BEST is sparse and heterogeneous, and prospective data are particularly limited.
This prospective observational study follows children and adults undergoing BEST as part of routine clinical care at Copenhagen University Hospital - Rigshospitalet.
The OVAMA questionnaire will be used to assess symptoms and appearance in all participants before treatment and at the 6-month follow-up. Depending on age, additional patient-reported measures will assess health-related quality of life (PROMIS-29) and pain (VAS) during follow-up. For adults, the study will assess changes in lesion size by comparing magnetic resonance imaging (MRI) scans performed before treatment and at 6 months. Adverse events will be recorded throughout follow-up.
The study aims to evaluate whether patient-reported outcomes improve during the 6 months after BEST and to provide further information about treatment safety.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Capital Region of Denmark
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Copenhagen, Capital Region of Denmark, Dinamarca, 2100
- Copenhagen University Hospital - Rigshospitalet
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Scheduled to undergo BEST as part of routine clinical care
- Diagnosis of a slow-flow vascular malformation confirmed by contrast-enhanced MRI performed within 6 months before enrollment.
Exclusion Criteria:
• Invasive treatment of the vascular malformation within 6 months before enrollment, including surgery, sclerotherapy, or laser treatment.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change from baseline in OVAMA (Outcome Measures for Vascular Malformations) questionnaire scale scores
Periodo de tiempo: Baseline and 6 months after BEST
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The OVAMA questionnaire is a condition-specific patient-reported outcome measure assessing symptoms and appearance related to vascular malformations.
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Baseline and 6 months after BEST
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline in PROMIS-29 (Patient-Reported Outcomes Measurement Information System) domain scores
Periodo de tiempo: Baseline and 6 months after BEST
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The Patient-Reported Outcomes Measurement Information System 29-item Profile (PROMIS-29) is a generic patient-reported outcome measure assessing physical, mental, and social health.
For participants aged 18 years or older.
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Baseline and 6 months after BEST
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Pain intensity measured using a visual analogue scale (VAS)
Periodo de tiempo: Baseline, 2 weeks, 1 month, 3 months, and 6 months after BEST
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Participants rate pain intensity using a VAS ranging from 0 (no pain) to 10 (worst imaginable pain).
For participants aged 7 years or older.
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Baseline, 2 weeks, 1 month, 3 months, and 6 months after BEST
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Change from baseline in vascular malformation size assessed by MRI
Periodo de tiempo: Baseline and 6 months after BEST
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MRI will be used to compare the size of the treated vascular malformation before BEST and 6 months after treatment.
For participants aged 18 years or older.
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Baseline and 6 months after BEST
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Number of participants with adverse events following BEST
Periodo de tiempo: From the day of the BEST procedure to the 6-month follow-up
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Adverse events occurring on the day of BEST or during follow-up will be recorded, including their nature, severity, management, and outcome.
Events will be classified according to the CIRSE and Clavien-Dindo classification systems.
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From the day of the BEST procedure to the 6-month follow-up
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Caroline Clausen, MD, PhD, Rigshospitalet, Denmark
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- p-2026-21479
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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