Comparative Study Between Sclerosing Agents Used in Treatment of Vascular Malformation

Ain Shams University

Status: Completed

Conditions: Vascular Malformation

Treatments: Procedure: Sclerotherapy with intralesional injection of polidocanol; Procedure: Sclerotherapy with intralesional bleomycin injection; Procedure: sclerotherapy with intralesional injection of Ethanol for treatment of low-flow vascular malformatio

Study type: Interventional

Funder types: Other

Identifiers

NCT07320430

FMASU MD15/2024

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups

first group(Ethanol)

Active Comparator group

Description:

* 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.

Treatment:

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

second group(Bleomycin)

Active Comparator group

Description:

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.

Treatment:

Procedure: Sclerotherapy with intralesional bleomycin injection

third group(Polidocanol)

Active Comparator group

Description:

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

Treatment:

Procedure: Sclerotherapy with intralesional injection of polidocanol