Lymphatic Malformation, Vascular Malformations, Venous Malformation
Conditions
Keywords
Bleomycin, Sclerotherapy, Head and Neck, Iraq
Brief summary
This study evaluated lesion volume reduction after intralesional bleomycin sclerotherapy in patients with low-flow vascular malformations of the head and neck, and identified predictors of treatment response. Twenty patients were enrolled across three Iraqi teaching hospitals and treated with intralesional bleomycin. Lesion volume was assessed by ultrasound or MRI at baseline and four weeks after the final treatment session.
Detailed description
Patients with clinically and radiologically confirmed low-flow vascular malformations of the head and neck were enrolled consecutively. Bleomycin was diluted to 3 mg/mL and injected intralesionally at multiple points, with a maximum of 15 mg per session and up to four sessions at three- to four-week intervals. Needle selection was guided by lesion depth, with ultrasound guidance used for deeper lesions. Lesion dimensions (length, width, depth) were measured by a single trained operator at each site; volume was calculated using the prolate ellipsoid formula (pi/6 x L x W x D), or by MRI-based volumetric segmentation for irregular multilocular lesions. Clinical response was graded using the modified Achauer scale. Adverse events were graded using CTCAE version 5.0, and peripheral oxygen saturation was monitored during and after each procedure.
Interventions
DRUGBleomycin (Bleocel 15)
Intralesional injection of bleomycin diluted with normal saline to 3 mg/mL. Maximum 15 mg per session; up to four sessions at three- to four-week intervals; cumulative dose capped at 400 mg. Administered under local anaesthesia or conscious sedation, with ultrasound guidance for deep lesions.
Sponsors
University Of Anbar
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age older than one year * Clinically and radiologically confirmed low-flow vascular malformation of the head and neck * No prior bleomycin therapy * Medically fit for outpatient intervention
Exclusion criteria
* High-flow vascular malformation * Pregnancy or lactation * Documented hypersensitivity to bleomycin * Pre-existing pulmonary or hepatic disease * Bleeding disorder or current anticoagulant use * Renal impairment (serum creatinine \> 1.5 mg/dL or estimated glomerular filtration rate \< 60 mL/min/1.73 m²) * Active infection at or near the treatment site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage reduction in lesion volume | Baseline to 4 weeks after the final treatment session | Lesion volume derived from three orthogonal dimensions using the prolate ellipsoid formula (pi/6 x length x width x depth) on ultrasound or MRI, or by MRI volumetric segmentation for irregular lesions. Percentage reduction calculated relative to baseline volume. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events | From the first treatment session through 4 weeks after the final treatment session, up to 16 weeks | Adverse events documented and graded using CTCAE version 5.0, including monitoring of peripheral oxygen saturation for pulmonary safety |
Countries
Iraq
Outcome results
None listed