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.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Capital Region of Denmark
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Copenhagen, Capital Region of Denmark, 덴마크, 2100
- Copenhagen University Hospital - Rigshospitalet
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline in OVAMA (Outcome Measures for Vascular Malformations) questionnaire scale scores
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline in PROMIS-29 (Patient-Reported Outcomes Measurement Information System) domain scores
기간: 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)
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Caroline Clausen, MD, PhD, Rigshospitalet, Denmark
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- p-2026-21479
개별 참가자 데이터(IPD) 계획
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