Comparative Study Between Sclerosing Agents Used in Treatment of Vascular Malformation

NCT ID: NCT07320430

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-14
• Study Completion Date: 2025-08-15

Brief Summary

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

Detailed Description

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

• Medications:
• Pre-operative: Prophylactic dose of anticoagulation will be given 5 days before operation for those with elevated D-dimer and will be continued for ten days post-operative.
• Intraoperative: Each patient will receive an injection of 0.5 mg/kg of corticosteroids during the procedure.
• Post-operative: PPI, oral corticosteroids- prednisolone 20mg once/day- for 5 days, anti-oedematous measures, and will be prescribed paracetamol tablets after the procedure.

• Follow up:

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.

Conditions

Vascular Malformation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

first group(Ethanol)

• 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.

Group Type: ACTIVE_COMPARATOR

sclerotherapy with intralesional injection of Ethanol for treatment of low-flow vascular malformatio

Intervention Type: PROCEDURE

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(Bleomycin)

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.

Group Type: ACTIVE_COMPARATOR

Sclerotherapy with intralesional bleomycin injection

Intervention Type: PROCEDURE

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(Polidocanol)

25 patients receiving Polidocanol 3% which will be foamed 1ml+4ml air to a maximum dose of 15 ml /session.

Group Type: ACTIVE_COMPARATOR

Sclerotherapy with intralesional injection of polidocanol

Intervention Type: PROCEDURE

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 .

Interventions

sclerotherapy with intralesional injection of Ethanol for treatment of low-flow vascular malformatio

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)

Intervention Type: PROCEDURE

Sclerotherapy with intralesional bleomycin injection

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 .

Intervention Type: PROCEDURE

Sclerotherapy with intralesional injection of polidocanol

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 .

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with schobinger stage II, III low- flow vascular malformation.
• Lesion affecting Patients trunk and extremity..
• Patient accepting the risk of the procedure and sign the detailed informed - consent, and in case of children-age less than18 years old- the consent will be signed by the parents

Exclusion Criteria

• Patient with high- flow vascular malformation.
• Patients with schobinger I and IV AVM.
• Lesion affecting face, head, and neck.
• Vascular tumours; haemangioma.
• Patient with hypersensitivity to embolic agents e.g., hypersensitivity to bleomycin.
• Patients with CKD and elevated serum creatinine level.
• Critically ill patients Including pulmonary diseases, insufficient cardiac and hepatorenal functions, systemic infection, haemorrhagic tendency.
• Patient who /or his parents don't accept the risk of our procedure and don't sign the detailed informed consent.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamed A Hagag, Lecturer, MD vascular surgery

Role: STUDY_DIRECTOR

faculty of medicine Ain shams Univerisity

Amr N kamel, professor of vascular surgery

Role: STUDY_DIRECTOR

faculty of medicine Ain shams Univerisity

Ayman A Mohamed, professor of vascular surgery

Role: STUDY_DIRECTOR

faculty of medicine Ain shams Univerisity

Locations

Faculty of medicine Ain Shams University

Cairo, Abbassia, Egypt

Countries

Egypt

Study Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Document Type: Analytic Code

View Document

Other Identifiers

FMASU MD15/2024

Identifier Type: -

Identifier Source: org_study_id