Clinical research of intralesional sclerotherapy in the oral and maxillofacial region

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-jRCTs071180067
• Date of registration: 20/03/2019
• Prospective Registration: No
• Primary sponsor: Danjo Atsushi
• Public title: Clinical research of intralesional sclerotherapy in the oral and maxillofacial region
• Scientific title: Clinical research for safty and efficacy in intralesional sclerotherapy with ethanolamine oleate for subcutaneous venous malformation in the oral and maxillofacial region - EOST-OMS
• Date of first enrolment: 23/10/2009
• Target sample size: 25
• Recruitment status: Recruiting
• URL: https://jrct.niph.go.jp/latest-detail/jRCTs071180067
• Study type: Interventional
• Study design: single arm study, open(masking not used), no treatment control/standard of care control, factorial assignment, treatment purpose
• Phase: 2

Contacts

• Name: Atsushi Danjo
• Affiliation: Saga University

• Name: Reona Aijima
• Affiliation: Saga University

Key inclusion & exclusion criteria

Inclusion criteria: 1.Venous malformation in the oral and maxillofacial region
2.Low-flow venous malformation diagnosed in contrasted MRI or CT
3.Both gender, any age
4.Written informed consent (<20 patients; Written informed consent by guardians)
Exclusion criteria: 1.24hCCr<70L/day or Creatinine Clearance estimate <60 ml/min
2.Unfit for the clinical research
3.Uncooperative for the treatments under local anesthesia

Age minimum: Not applicable
Age maximum: Not applicable
Gender: Both

Health Condition(s) or Problem(s) studied

Sclerotherapy, Venous malformation, ethanolamine oleate

Venous malformation in the oral and maxillofacial region
Sclerotherapy, Venous malformation, ethanolamine oleate

angioma, venous

Intervention(s)

sclerotherapy

Single arm study, open (masking not used), no assignment
All procedures will be done with oral surgeon and radiologist in angiography room. (For superficial lesion, procedures will be done with intermittent simple X-ray for reduction of exposure, despite using angiography to confirm drainage veins in oral and maxillofacial outpatient clinic.)
1. Local anesthesia into the lesion.
2. Puncture with 22-24G needle and confirm the backflow of blood.
3. Stabilize the needle and check the distribution and blood flow of the lesion by angiography and computed tomography (CT) with contrast medium. If there is any risk that sclerosing agent will escape whole body, we must decide the cancellation of the trial. If we can block the drainage vein over 5 minutes, we decide that the trial can continue. (For superficial lesions, we inject contrast medium in oral and maxillofacial outpatient clinic and confirm retention of contrast medium using intermittent simple X-ray.)
4. Treat with injection 5% ethanolamine oleate(EO) (diluted by Iopamiron 300) . Volume of the 5%EO will be decided by situation, but the maximum volume is 20ml (5% EO) by one treatment. After 5 minites, the 5%EO collect as possible.
5. Check the hemostasis of the injection point(s).

Primary Outcome(s)

Reduction rate

Secondary Outcome(s)

Adverse events: rate, details, severity, recurrence rate

Ethics review

Status: Approval
Approval date:
Contact:

[e-mail]

Saga University Clinical Research Review Board

[phone]

[e-mail]