Comparative Study Between Sclerosing Agents Used in Treatment of Vascular Malformation

NCT07320430 | Completed

• 1 other identifier: FMASU MD15/2024
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vascular Malformation

Keywords

low-flow; sclerosing; vascular malformation

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months after the last procedure

Secondary Outcomes (2)

• Rate of complications .

  within1 months after the last procedure

• patient satisfaction

  within 1 month after last procedure.

Study Arms (3)

first group(Ethanol)

ACTIVE COMPARATOR

* 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

second group(Bleomycin)

ACTIVE COMPARATOR

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

third group(Polidocanol)

ACTIVE COMPARATOR

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

Interventions

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

first group(Ethanol)

Sclerotherapy with intralesional bleomycin injection 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 .

second group(Bleomycin)

Sclerotherapy with intralesional injection of polidocanol 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 .

third group(Polidocanol)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of medicine Ain Shams University

Cairo, Abbassia, 00202, Egypt

Location

MeSH Terms

Conditions

Vascular Malformations

Interventions

Sclerotherapy

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: January 6, 2026
• Study Start: February 14, 2024
• Primary Completion: July 15, 2025
• Study Completion: August 15, 2025
• Last Updated: January 6, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

EG (1)