Comparative Study Between the Efficacy and Safety of Different Sclerosing Agents Used in Treatment of Low-Flow Vascular Malformation

This study aims to Compare the Efficacy and Safety of Different sclerosing Agents Used in Treatment of Low-Flow Vascular Malformation.

Study Population: Patients with low -flow vascular malformations who visit Ain Shams University hospitals outpatient clinic.

• Type of Study: Randomized Controlled Clinical Trial.

• Study Setting: Ain Shams University hospitals.

• Study Period: 18 months.

• Sample Size: 75 patients.

• Sampling Method: Convenient sample, divided into three equal groups by closed enveloped method.

• First group will receive ethanol, second group will receive bleomycin, and third group will receive polidocanol.

* Study procedure: patients will be lying flat supine or prone according to the anatomical site of the lesion, torniquet is applied over the draining vein , US guided puncture of the VM using 21gauge butterfly needle under local, regional or light general anaesthesia according to the topography of the lesion and patient's age, when flow seen, contrast is used to confirm correct access, visualization of the vascular channels and any connection with arterial or deep venous system, injection of the sclerosing agent under fluoroscopy showing contrast displacement.

• Ethanol 99.8% with maximum dose 1ml/kg/session, bleomycin (15 U per bottle) will be reconstituted with 10 mL of normal saline to a final concentration of 1.5 U/ML, then 4ml will be foamed with 6ml human albumin, polidocanol 3% will be foamed 1ml+4ml air to a maximum dose of 15 ml /session.
• First group will receive ethanol, second group will receive bleomycin, and third group will receive polidocanol.
• After injection, DSA to allow visualization of negative or reduced dye filling, needle will be removed, then compression with bandage except for ethanol group, with mean procedure time about 20 minutes