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

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• 作者：Takao Hiraki ; Jun Koizumi ; Yasuaki Arai ; Yasuo Sakurai…
• 关键词：Transcatheter arterial embolization ; Hypervascular tumor ; Microsphere ; HepaSphere
• 刊名：Japanese Journal of Radiology
• 出版年：2015
• 出版时间：August 2015
• 年：2015
• 卷：33
• 期：8
• 页码：479-486
• 全文大小：412 KB
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• 作者单位：Takao Hiraki (1)
  Jun Koizumi (2)
  Yasuaki Arai (3)
  Yasuo Sakurai (4)
  Hiromitsu Kumada (5)
  Yoshihiro Nambu (6)
  Shinichi Hori (7)
  
  1. Department of Radiology, Okayama University Medical School, 2-5-1 Shikatacho, Okayama, 700-8558, Japan
  2. Department of Radiology, Tokai University School of Medicine, Isehara, Japan
  3. Department of Diagnostic Radiology, National Cancer Center Hospital, Tokyo, Japan
  4. Department of Diagnostic Radiology, Teine-Keijinkai Hospital, Sapporo, Japan
  5. Department of Hepatology, Toranomon Hospital, Tokyo, Japan
  6. Pharmaceutical Development Division, Nippon Kayaku Co., Ltd., Tokyo, Japan
  7. Department of Radiology, Gate Tower Institute for Image Guided Therapy, Izumisano, Japan
  
• 刊物主题：Imaging / Radiology; Nuclear Medicine; Radiotherapy;
• 出版者：Springer Japan
• ISSN：1867-108X

文摘

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).