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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studieorter
-
-
Capital Region of Denmark
-
Copenhagen, Capital Region of Denmark, Danmark, 2100
- Copenhagen University Hospital - Rigshospitalet
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from baseline in OVAMA (Outcome Measures for Vascular Malformations) questionnaire scale scores
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from baseline in PROMIS-29 (Patient-Reported Outcomes Measurement Information System) domain scores
Tidsram: Baseline and 6 months after BEST
|
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.
|
Baseline and 6 months after BEST
|
|
Pain intensity measured using a visual analogue scale (VAS)
Tidsram: Baseline, 2 weeks, 1 month, 3 months, and 6 months after BEST
|
Participants rate pain intensity using a VAS ranging from 0 (no pain) to 10 (worst imaginable pain).
For participants aged 7 years or older.
|
Baseline, 2 weeks, 1 month, 3 months, and 6 months after BEST
|
|
Change from baseline in vascular malformation size assessed by MRI
Tidsram: Baseline and 6 months after BEST
|
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.
|
Baseline and 6 months after BEST
|
|
Number of participants with adverse events following BEST
Tidsram: From the day of the BEST procedure to the 6-month follow-up
|
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.
|
From the day of the BEST procedure to the 6-month follow-up
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Caroline Clausen, MD, PhD, Rigshospitalet, Denmark
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- p-2026-21479
Plan för individuella deltagardata (IPD)
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