Objective To evaluate the efficacy and safety of sclerotherapy in patients with difficult-to-resect venous malformations treated with ethanolamine oleate. Design and setting This investigator-initiated clinical trial employed a multicenter, single-arm, open-label design and was conducted in Japan. Patients Overall, 44 patients with difficult-to-resect venous malformations were categorized into two cohorts: 22 patients with cystic-type malformations and 22 patients with diffuse-type malformations. Interventions Patients received injections of 5% ethanolamine oleate solution, double diluted with contrast or normal saline, with a maximum dose of 0.4 mL/kg. The same method of administration was used for children (<15 years old). The maximum volume of the prepared solution in one treatment was 30 mL. Evaluation methods Treatment efficacy was assessed by evaluating changes in lesion volume using magnetic resonance imaging and changes in pain using a visual analog scale. Results Among the 45 patients who consented, one was excluded owing to potential intracranial involvement of venous malformations during screening. Regarding the primary outcome, 26 of 44 patients (59.1%, 95% confidence interval: 44.41-72.31%) achieved ≥ 20% reduction in malformation volume, with 16 patients having cystic lesions (72.7%, 51.85-86.85%) and 10 patients having diffuse lesions (45.5%, 26.92-65.34%). Both cohorts showed significant improvement in self-reported pain scores associated with lesions 3 months post-sclerotherapy. No death or serious adverse events occurred. Hemoglobinuria was observed in 23 patients (52%), a known drug related adverse event. Prompt initiation of haptoglobin therapy led to full recovery within a month for these patients. Conclusions Ethanolamine oleate shows potential as a therapeutic sclerosing agent for patients with difficult-to-resect venous malformations.
Competing Interest StatementThe authors have declared no competing interest.
Clinical TrialjRCT2051200046
Clinical Protocolshttps://jrct.niph.go.jp/re/reports/detail/71531
Funding StatementThis study was funded by the Japan Agency for Medical Research and Development (AMED), Grant Number JP20lk0201115.
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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
Kyorin University Hospital Institutional Review Board gave ethical approval for this work. Kobe University Hospital Institutional Review Board gave ethical approval for this work. Osaka Medical and Pharmaceutical University Hospital Institutional Review Board gave ethical approval for this work. National University Corporation Shinshu University School of Medicine Hospital Institutional Review Board gave ethical approval for this work. The University of Tokyo Hospital Institutional Review Board gave ethical approval for this work. Juntendo University Urayasu Hospital Institutional Review Board gave ethical approval for this work. Keio University Hospital Institutional Review Board gave ethical approval for this work. National Center for Child Health and Development Institutional Review Board gave ethical approval for this work.
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