Vascular Malformations
Conditions
Brief summary
The aim of the BEST study is to examine the feasibility of assessing patient and clinician reported outcome of a single electrosclerotherapy treatment of vascular malformations. * Sclerotherapy = injection of Bleomycin into vascular birthmarks to seal off abnormal vascular channels * Electroporation = application of an electric field to vessels treated with a handheld needle electrode * Electrosclerotherapy = a combination of Bleomycin sclerotherapy and electroporation
Interventions
OTHERBleomycin electrosclerotherapy treatment
The combination of Bleomycin and electroporation of the treated area which is called electrochemotherapy (ECT).
Sponsors
Teesside University
South Tees Hospitals NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
single group of patients receiving same treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* New patients presenting with a vascular malformation suitable for Bleomycin sclerotherapy treatment * Existing patients presenting with a poor response to treatment, performed more than 6 months ago * Placement of a needle electrode into the vascular malformation is technically possible * Evaluation of response to treatment is possible on photo documentation * Patients agreeing to participate in the study * The ability to understand written and spoken English
Exclusion criteria
* Patients not agreeing to participate in the study * Pregnancy * Breastfeeding * Previous high systemic Bleomycin exposure (more than 3000 IU) * Patients unable to provide written, informed consent * Patients in which needle electrode placement is not possible * Response to treatment not evaluable by photo documentation * Patients unable to speak English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of life questionnaire scores between baseline and 6-8 weeks of treatment | 8 weeks | Patient reported quality of life after a single electrosclerotherapy treatment of vascular malformations - change in scores measured using Birthmark Quality of Life questionnaire (8 items measured on 5 point scale) |
| Clinician assessment tool of treatment response | 8 weeks | Clinician assessment of treatment response following electrosclerotherapy treatment using clinical assessment tool - change in scores measured |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To collect documented side effects following electrosclerotherapy treatment. | 2 years | To collect documented side effects following electrosclerotherapy treatment using diary |
Countries
United Kingdom
Contacts
Primary ContactClare Proctor
Backup ContactHyder Latif, BA (hons)
Outcome results
None listed