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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiesteder
-
-
Capital Region of Denmark
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Copenhagen, Capital Region of Denmark, Danmark, 2100
- Copenhagen University Hospital - Rigshospitalet
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in OVAMA (Outcome Measures for Vascular Malformations) questionnaire scale scores
Tidsramme: Baseline and 6 months after BEST
|
The OVAMA questionnaire is a condition-specific patient-reported outcome measure assessing symptoms and appearance related to vascular malformations.
|
Baseline and 6 months after BEST
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in PROMIS-29 (Patient-Reported Outcomes Measurement Information System) domain scores
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Caroline Clausen, MD, PhD, Rigshospitalet, Denmark
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- p-2026-21479
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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