Intralesional Bleomycin Sclerotherapy for Low-Flow Vascular Malformations of the Head and Neck

University Of Anbar20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Vascular Malformations Venous Malformation Lymphatic Malformation

Interventions

Bleomycin (Bleocel 15)DRUG

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.

Eligibility

Sex: ALLMin age: 1 Year

Medical Language ↔ Plain English

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

Locations (3)

Al-Fallujah Teaching Hospital

Fallujah, Al-Anbar Governorate, Iraq

Al-Najaf Al-Ashraf Teaching Hospital

Najaf, Najaf, Iraq

Al-Sadr Teaching Hospital

Najaf, Najaf, Iraq

Outcomes

Primary Outcomes

Percentage reduction in lesion volume

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.

Time frame: Baseline to 4 weeks after the final treatment session

Secondary Outcomes

Incidence and severity of adverse events

Adverse events documented and graded using CTCAE version 5.0, including monitoring of peripheral oxygen saturation for pulmonary safety

Time frame: From the first treatment session through 4 weeks after the final treatment session, up to 16 weeks

Data from ClinicalTrials.gov

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