Iopamiron ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
279Huge venous malformation with cervical, oral and pharyngeal diffuse lesion1

279. Huge venous malformation with cervical, oral and pharyngeal diffuse lesion


Clinical trials : 14 Drugs : 24 - (DrugBank : 9) / Drug target genes : 3 - Drug target pathways : 105
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1JPRN-jRCTs071180067
23/10/200920/03/2019Clinical research of intralesional sclerotherapy in the oral and maxillofacial regionClinical research for safty and efficacy in intralesional sclerotherapy with ethanolamine oleate for subcutaneous venous malformation in the oral and maxillofacial region - EOST-OMS Venous malformation in the oral and maxillofacial region
Sclerotherapy, Venous malformation, ethanolamine oleate;angioma, venous
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).
Danjo AtsushiNULLRecruitingNot applicableNot applicableBoth25Phase 2Japan