Transcatheter arterial embolization of hypervascular tumors with HepaSphere: prospective multicenter open label clinical trial of microspheres in Japan

Takao Hiraki, Jun Koizumi, Yasuaki Arai, Yasuo Sakurai, Hiromitsu Kumada, Yoshihiro Nambu, Shinichi Hori

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Purpose: To evaluate the feasibility and safety of transcatheter arterial embolization (TAE) with the use of HepaSphere microspheres for hypervascular tumors. Materials and methods: This was a prospective multicenter open label clinical trial involving six institutions in Japan. TAE was performed with the HepaSphere microspheres for hypervascular tumors in various locations. The endpoint of the study was the feasibility and safety of the procedure. The feasibility and safety were evaluated according to technical success and adverse events, respectively. Adverse events that were related to TAE were evaluated by using the Common Terminology Criteria for Adverse Events, version 4.0. Results: Twenty-four patients were enrolled. The technical success rate was 100 % (24/24). Twenty-two (92 %) patients developed a total of 50 symptomatic adverse events, including 30 grade 1 events, 17 grade 2 events, and 3 grade 3 events. The most frequent adverse event was fever with an incidence of 63 %, followed by abdominal pain (25 %). Conclusion: TAE for hypervascular tumors with the HepaSphere microspheres was feasible and rarely caused major adverse events. Trial registration: This trial was registered in JAPIC Clinical Trials Information (JapicCTI-111534).

Original languageEnglish
Pages (from-to)479-486
Number of pages8
JournalJapanese Journal of Radiology
Volume33
Issue number8
DOIs
Publication statusPublished - Aug 21 2015

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Keywords

  • HepaSphere
  • Hypervascular tumor
  • Microsphere
  • Transcatheter arterial embolization

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

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