An interventional study of sclerotherapy with intralesional injection of Ethanol for treatment of low-flow vascular malformatio and Sclerotherapy with intralesional bleomycin injection in Vascular Malformation, sponsored by Ain Shams University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
This study aims to Compare 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.
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.
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
* Medications:
Post-operative: PPI, oral corticosteroids- prednisolone 20mg once/day- for 5 days, anti-oedematous measures, and will be prescribed paracetamol tablets after the procedure.
The investigators will follow those patients clinically, and radiologically (follow up US\&MRI selectively).
patients will be followed up few hours after operation, 2-4 weeks later between sessions, decision to continue the treatment or not will be made with the patient on the basis of the clinical efficacy. At the end of the treatment, patients will be followed up in a non-standardised manner up to 18 months, usually 1-3 months after the last session. When a consultation was not possible, telephone contact will be made with the patient.
79 studies on the registry are indexed under Vascular Malformations; 33 are open to participants now.
This study's enrollment of 75 is above the median of 55 across 49 interventional studies indexed under Vascular Malformations.
Browse Vascular Malformations studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 25 patients receiving Ethanol 99.8% with maximum dose 1ml/kg/session * sclerotherapy with intralesional injection of ethanol for treatment of low-flow vascular malformation.
Procedure: sclerotherapy with intralesional injection of Ethanol for treatment of low-flow vascular malformatio
25 patients receiving 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. sclerotherapy with intralesional injection of bleomycin for treatment of low-flow vascular malformation.
Procedure: Sclerotherapy with intralesional bleomycin injection
25 patients receiving Polidocanol 3% which will be foamed 1ml+4ml air to a maximum dose of 15 ml /session.
Procedure: Sclerotherapy with intralesional injection of polidocanol
First group will receive Ethanol. patients will be lying flat supine or prone according to the anatomical site of the lesion, US guided puncture of the vascular malformation (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(Ethanol 99.8% with maximum dose 1ml/kg/session ) under fluoroscopy showing contrast displacement. After injection, DSA to allow visualization of negative or reduced dye filling, needle will be removed. compression will not be done for this group for fear of complications ( post operative pain- skin gangrene)
second group will receive bleomycin. patients will be lying flat supine or prone according to the anatomical site of the lesion, US guided puncture of the vascular malformation (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: 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, under fluoroscopy showing contrast displacement. After injection, DSA to allow visualization of negative or reduced dye filling, needle will be removed, then compression with bandage will be done .
Third group will receive polidocanol. 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. polidocanol 3% will be foamed 1ml+4ml air to a maximum dose of 15 ml /session. After injection DSA to DSA to allow visualization of negative or reduced dye filling, needle will be removed, then compression with bandage .
cure rate
cure rate defined as: 1. Complete cure as 100% lesion devascularization on DSA or US with complete resolution of initial symptoms and signs. 2. partial cure has been established as devascularization of 50%-99% with complete or partial resolution.
Time frame: 3 months after the last procedure
Rate of complications .
1-Rate of complications including( pain, skin rash, hyperpigmentation, hypersensitivity reaction, PE
Time frame: within1 months after the last procedure
patient satisfaction
Level of patient's satisfaction expressed through 5-point Likert scale. Items included are: 1. Post-Operative Pain Management . 2. Cosmetic Improvement . 3. Functional improvement . 4. Communication with the investigator about the case (diagnosis\& management). 5. Follow up after intervention. Overall Lowest score (5)means worst outcome, while Overall highest score (25)means best outcome.
Time frame: within 1 month after last procedure.
Plan to share: Yes — All available demographic data, photos taken before, during and after procedures, results can be shared
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.