Clinical research of intralesional sclerotherapy in the oral and maxillofacial region

JRCT ID: jRCTs071180067

Registered date:20/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Venous malformation in the oral and maxillofacial region
• Date of first enrollment: 23/10/2009
• Target sample size: 25
• Study type: Interventional

Intervention(s)

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).

Outcome(s)

• Primary Outcome: Reduction rate
• Secondary Outcome: Adverse events: rate, details, severity, recurrence rate

Key inclusion & exclusion criteria

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

Include 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)

Exclude 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

Related Information

• Primary Sponsor: Danjo Atsushi