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Transarterial embolization of hypervascular tumors using trisacryl gelatin microspheres (Embosphere): a prospective multicenter clinical trial in Japan

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Abstract

Purpose

To evaluate the feasibility and safety of transarterial embolization (TAE) using trisacryl gelatin microspheres (TGMs) for hypervascular tumors.

Materials and methods

This was a prospective multicenter clinical trial involving five institutions. TAE using TGMs was performed for hypervascular tumors in various locations. The primary endpoint was the technical success. The secondary endpoints included catheter accessibility, preservation of the feeding arteries, local tumor response based on the Response Evaluation Criteria in Cancer of the Liver (RECICL) and adverse events related to TAE based on the Common Terminology Criteria for Adverse Events, version 4.0.

Results

Twenty-three patients with liver tumors (n = 9), uterine fibroids (n = 3) and other tumors (n = 11) were enrolled. The technical success rate was 95.7 % (22 of 23 patients). Catheter accessibility and preservation of the feeding arteries were obtained in all 55 target vessels (100 %). Local tumor response rates were 46.7 and 55.8 % at 4 and 12 weeks, respectively. Eighteen (78.3 %) patients developed 53 symptomatic events including grade ≧3 events: hypertension 21.7 %, pain 8.7 %, vomiting 4.3 % and anorexia 4.3 %, all related to postembolization syndromes.

Conclusion

TAE using TGMs was technically feasible and safe for devascularization of hypervascular tumors.

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Acknowledgments

We thank Hiraku Yodono, Tadashi Kimura and Takafumi Ichida for evaluation of the technical success as members of an independent assessment committee. This study was financially supported by Nippon Kayaku Co., Ltd. All study sites and institutions received funding from Nippon Kayaku for the clinical trial execution.

Author information

Authors and Affiliations

  1. Department of Diagnostic and Interventional Radiology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan

    Keigo Osuga

  2. Department of Radiology, St. Marianna University School of Medicine, Kawasaki, Japan

    Yasuo Nakajima

  3. Department of Radiology, Iwate Medical University, Morioka, Japan

    Miyuki Sone

  4. Department of Diagnostic Radiology, National Cancer Center Hospital, Tokyo, Japan

    Miyuki Sone & Yasuaki Arai

  5. Pharmaceuticals Group, Nippon Kayaku Co. Ltd., Tokyo, Japan

    Yoshihiro Nambu

  6. Department of Radiology, Gate Tower Institute for Image Guided Therapy, Izumisano, Japan

    Shinichi Hori

Authors
  1. Keigo Osuga
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  2. Yasuo Nakajima
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  3. Miyuki Sone
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  4. Yasuaki Arai
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  5. Yoshihiro Nambu
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  6. Shinichi Hori
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Corresponding author

Correspondence to Keigo Osuga.

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Conflict of interest

Yoshihiro Nambu is an employee of Nippon Kayaku. Yasuo Nakajima, Yasuaki Arai and Shinichi Hori received consultation and lecture fees from Nippon Kayaku. Miyuki Sone received a manuscript fee from Nippon Kayaku. Keigo Osuga received manuscript fees and will receive honoraria after publication for drafting of this manuscript from Nippon Kayaku.

Ethical statement

All procedures performed in studies involving human participants were in accordance with “good clinical practice” (GCP), all applicable subject privacy requirements and the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Additional information

This study was registered with the JAPIC Clinical Trials Information Center (JapicCTI-101284) (http://www.clinicaltrials.jp/user/cteSearch_e.jsp).

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Osuga, K., Nakajima, Y., Sone, M. et al. Transarterial embolization of hypervascular tumors using trisacryl gelatin microspheres (Embosphere): a prospective multicenter clinical trial in Japan. Jpn J Radiol 34, 366–375 (2016). https://doi.org/10.1007/s11604-016-0535-5

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  • DOI: https://doi.org/10.1007/s11604-016-0535-5

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