Evaluation of the Efficacy of Intralesional Bleomycin Injections for the Treatment of Low-Flow Vascular Malformations: A Multi-Center Study in Iraq
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Percentage reduction in lesion volume
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Percentage reduction in lesion volume
时间窗: 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.
次要结局
- Incidence and severity of adverse events(From the first treatment session through 4 weeks after the final treatment session, up to 16 weeks)
研究者
Ahmed Tawfeeq Amoori
Postgraduate Researcher, Department of Oral and Maxillofacial Surgery
University Of Anbar