Comparative Study Between Sclerosing Agents Used in Treatment of Vascular Malformation

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 Overview

• Status: Completed
• Conditions: Vascular Malformation
• Intervention / Treatment: Procedure: sclerotherapy with intralesional injection of Ethanol for treatment of low-flow vascular malformatio; Procedure: Sclerotherapy with intralesional bleomycin injection; Procedure: Sclerotherapy with intralesional injection of polidocanol

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Abbassia
    • Cairo, Abbassia, Egypt, 00202
      • Faculty of Medicine Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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)
Active Comparator: 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.	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 .
Active Comparator: third group(Polidocanol); 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; 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cure rate	cure rate defined as: Complete cure as 100% lesion devascularization on DSA or US with complete resolution of initial symptoms and signs.; partial cure has been established as devascularization of 50%-99% with complete or partial resolution.	3 months after the last procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of complications .	1-Rate of complications including( pain, skin rash, hyperpigmentation, hypersensitivity reaction, PE	within1 months after the last procedure
patient satisfaction	Level of patient's satisfaction expressed through 5-point Likert scale. Items included are: Post-Operative Pain Management .; Cosmetic Improvement .; Functional improvement .; Communication with the investigator about the case (diagnosis& management).; Follow up after intervention. Overall Lowest score (5)means worst outcome, while Overall highest score (25)means best outcome.	within 1 month after last procedure.

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Mohamed A Hagag, Lecturer, MD vascular surgery, faculty of medicine Ain shams Univerisity; Study Director: Amr N kamel, professor of vascular surgery, faculty of medicine Ain shams Univerisity; Study Director: Ayman A Mohamed, professor of vascular surgery, faculty of medicine Ain shams Univerisity

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2024
• Primary Completion (Actual): July 15, 2025
• Study Completion (Actual): August 15, 2025

Study Registration Dates

• First Submitted: June 15, 2025
• First Submitted That Met QC Criteria: December 25, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 25, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: vascular malformation; low-flow; sclerosing
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Vascular Malformations; Therapeutics; Drug Therapy; Sclerotherapy
• Other Study ID Numbers: FMASU MD15/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All available demographic data, photos taken before, during and after procedures, results can be shared
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Study Data/Documents

1. Study Protocol
2. Informed Consent Form
3. Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No