279. 巨大静脈奇形（頚部口腔咽頭びまん性病変） Huge venous malformation with cervical, oral and pharyngeal diffuse lesion Clinical trials / Disease details
臨床試験数 : 15 / 薬物数 : 24 - (DrugBank : 10) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 105
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-jRCT2051200046 | 15/01/2021 | 25/08/2020 | A study for evaluation of efficacy and safety of ethanolamine oleate in patients with venous malformations | Evaluation of efficacy and safety of ethanolamine oleate in sclerotherapy in patients with venous malformations: A multicenter, open-label, single-arm study - EO-1 | Venous malformation difficult to remove | Injection of 5% ethanolamine oleate which is double diluted by contrast or normal saline for the venous malformation, within maximum dosage of 0.4 mL/kg. Same method of administration is performed for children. Maximum volume of the drug in once treatment is 30 mL after preparation. | Nomura Tadashi | Nomura Tadashi;Ozaki Mine | Recruiting | Not applicable | Not applicable | Both | 44 | Phase 3 | Japan |
| 2 | JPRN-jRCTs071180067 | 23/10/2009 | 20/03/2019 | Clinical research of intralesional sclerotherapy in the oral and maxillofacial region | Clinical 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 Atsushi | NULL | Recruiting | Not applicable | Not applicable | Both | 25 | Phase 2 | Japan |