Comparative Study Between Sclerosing Agents Used in Treatment of Vascular Malformation

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

Interventions

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)

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 .

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 .

Sponsors & Collaborators

• Ain Shams University

  lead OTHER

Principal Investigators

• Mohamed A Hagag, Lecturer, MD vascular surgery · faculty of medicine Ain shams Univerisity

• Amr N kamel, professor of vascular surgery · faculty of medicine Ain shams Univerisity

• Ayman A Mohamed, professor of vascular surgery · faculty of medicine Ain shams Univerisity

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-02-14

Primary Completion

2025-07-15

Completion

2025-08-15

Countries

• Egypt

Study Locations