Skip to main content
SpringerLink
Log in

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

  • Original Article
  • Published:
Japanese Journal of Radiology Aims and scope Submit manuscript

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).

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Nakamura H, Hashimoto T, Oi H, Sawada S. Transcatheter oily chemoembolization of hepatocellular carcinoma. Radiology. 1989;170:783–6.

    Article  CAS  PubMed  Google Scholar 

  2. Uchida H, Ohishi H, Matsuo N, et al. Transcatheter hepatic segmental arterial embolization using lipiodol mixed with an anticancer drug and Gelfoam particles for hepatocellular carcinoma. Cardiovasc Intervent Radiol. 1990;13(3):140–5.

    Article  CAS  PubMed  Google Scholar 

  3. Hodaka ATY, Hidehiko K. A Case of non-functioning islet cell carcinoma with multiple liver metastases–cemplete responce to transcatheter arterial ernbolization. Jpn J Gastroenterol Surg. 1992;25:3002–6.

    Article  Google Scholar 

  4. Yamada R, Sato M, Kawabata M, Nakatsuka H, Nakamura K, Takashima S. Hepatic artery embolization in 120 patients with unresectable hepatoma. Radiology. 1983;148(2):397–401.

    Article  CAS  PubMed  Google Scholar 

  5. Takayasu K, Arii S, Ikai I, et al. Prospective cohort study of transarterial chemoembolization for unresectable hepatocellular carcinoma in 8510 patients. Gastroenterology. 2006;131(2):461–9.

    Article  CAS  PubMed  Google Scholar 

  6. Katsumori T, Kasahara T. The size of gelatin sponge particles: differences with preparation method. Cardiovasc Intervent Radiol. 2006;29(6):1077–83.

    Article  PubMed  Google Scholar 

  7. Yamada R, Sawada S, Uchida H, et al. Clinical study of porous gelatin sphere (YM 670) in transcatheter arterial embolization. Gan to kagaku ryoho. 2005;32(10):1431–6.

    PubMed  Google Scholar 

  8. Osuga K, Anai H, Takahashi M, et al. Porous gelatin particles for hepatic arterial embolization; investigation of the size distribution and fragmentation before and after microcatheter passage. Gan to kagaku ryoho. 2009;36:437–42.

    PubMed  Google Scholar 

  9. Laurent A. Microspheres and nonspherical particles for embolization. Tech Vasc Interv Radiol. 2007;10(4):248–56.

    Article  CAS  PubMed  Google Scholar 

  10. Lewis AL, Adams C, Busby W, et al. Comparative in vitro evaluation of microspherical embolisation agents. J Mater Sci Mater Med. 2006;17(12):1193–204.

    Article  CAS  PubMed  Google Scholar 

  11. Laurent A, Beaujeux R, Wassef M, Rufenacht D, Boschetti E, Merland JJ. Trisacryl gelatin microspheres for therapeutic embolization, I: development and in vitro evaluation. AJNR Am J Neuroradiol. 1996;17(3):533–40.

    CAS  PubMed  Google Scholar 

  12. Beaujeux R, Laurent A, Wassef M, et al. Trisacryl gelatin microspheres for therapeutic embolization, II: preliminary clinical evaluation in tumors and arteriovenous malformations. AJNR Am J Neuroradiol. 1996;17(3):541–8.

    CAS  PubMed  Google Scholar 

  13. de Luis E, Bilbao JI, de Ciercoles JA, de Martinez-Cuesta A, Martino Rodriguez A, Lozano MD. In vivo evaluation of a new embolic spherical particle (HepaSphere) in a kidney animal model. Cardiovasc Intervent Radiol. 2008;31(2):367–76.

    Article  PubMed  Google Scholar 

  14. Hori S, Okada A, Sakamoto K. A new embolic material: superabsorbent polymer microsphere and its embolic effects. Jpn J Interv Radiol. 1996;11:375–81.

    Google Scholar 

  15. Lee KH, Liapi EA, Cornell C, et al. Doxorubicin-loaded QuadraSphere microspheres: plasma pharmacokinetics and intratumoral drug concentration in an animal model of liver cancer. Cardiovasc Intervent Radiol. 2010;33(3):576–82.

    Article  PubMed Central  PubMed  Google Scholar 

  16. Lewis AL, Gonzalez MV, Lloyd AW, et al. DC bead: in vitro characterization of a drug-delivery device for transarterial chemoembolization. J Vasc Interv Radiol. 2006;17:335–42.

    Article  PubMed  Google Scholar 

  17. Osuga K, Hori S, Hiraishi K, et al. Bland embolization of hepatocellular carcinoma using superabsorbent polymer microspheres. Cardiovasc Intervent Radiol. 2008;31(6):1108–16.

    Article  PubMed  Google Scholar 

  18. Grosso M, Vignali C, Quaretti P, et al. Transarterial chemoembolization for hepatocellular carcinoma with drug-eluting microspheres: preliminary results from an Italian multicentre study. Cardiovasc Intervent Radiol. 2008;31(6):1141–9.

    Article  PubMed  Google Scholar 

  19. Jiaqi Y, Hori S, Minamitani K, et al. A new embolic material: super absorbent polymer (SAP) microsphere and its embolic effects. Nippon Igaku Hoshasen Gakkai Zasshi. 1996;56(1):19–24.

    CAS  PubMed  Google Scholar 

  20. Chen AP, Setser A, Anadkat MJ, et al. Grading dermatologic adverse events of cancer treatments: the common terminology criteria for adverse Events Version 4.0. J Am Acad Dermatol. 2012;67(5):1025–39.

    Article  PubMed  Google Scholar 

  21. Khankan AA, Osuga K, Hori S, Morii E, Murakami T, Nakamura H. Embolic effects of superabsorbent polymer microspheres in rabbit renal model: comparison with tris-acryl gelatin microspheres and polyvinyl alcohol. Radiat Med. 2004;22(6):384–90.

    PubMed  Google Scholar 

  22. Seki A, Hori S, Sueyoshi S, Hori A, Kono M, Murata S, et al. Transcatheter arterial embolization with spherical embolic agent for pulmonary metastases from renal cell carcinoma. Cardiovasc Intervent Radiol. 2013;36:1527–35.

    Article  PubMed  Google Scholar 

  23. Seki A, Hori S, Kobayashi K, Narumiya S. Transcatheter arterial chemoembolization with epirubicin-loaded superabsorbent polymer microspheres for 135 hepatocellular carcinoma patients: single-center experience. Cardiovasc Intervent Radiol. 2011;34(3):557–65.

    Article  PubMed  Google Scholar 

  24. Huppert P, Wenzel T, Wietholtz H. Transcatheter arterial chemoembolization (TACE) of colorectal cancer liver metastases by irinotecan-eluting microspheres in a salvage patient population. Cardiovasc Intervent Radiol. 2014;37(1):154–64.

    Article  PubMed  Google Scholar 

  25. Jarzabek M, Jargiello T, Wolski A, Poluha P, Szczerbo-Trojanowska M. Drug-eluting microspheres transarterial chemoembolization (DEM TACE) in patients with liver metastases. Pilot study. Pol J Radiol. 2011;76(3):26–32.

    PubMed Central  PubMed  Google Scholar 

Download references

Acknowledgments

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

Author information

Authors and Affiliations

  1. Department of Radiology, Okayama University Medical School, 2-5-1 Shikatacho, Okayama, 700-8558, Japan

    Takao Hiraki

  2. Department of Radiology, Tokai University School of Medicine, Isehara, Japan

    Jun Koizumi

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

    Yasuaki Arai

  4. Department of Diagnostic Radiology, Teine-Keijinkai Hospital, Sapporo, Japan

    Yasuo Sakurai

  5. Department of Hepatology, Toranomon Hospital, Tokyo, Japan

    Hiromitsu Kumada

  6. Pharmaceutical Development Division, Nippon Kayaku Co., Ltd., Tokyo, Japan

    Yoshihiro Nambu

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

    Shinichi Hori

Authors
  1. Takao Hiraki
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Jun Koizumi
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Yasuaki Arai
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Yasuo Sakurai
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Hiromitsu Kumada
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Yoshihiro Nambu
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Shinichi Hori
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Takao Hiraki.

Ethics declarations

Conflict of interest

Yoshihiro Nambu is an employee of Nippon Kayaku. Yasuaki Arai and Shinichi Hori received consultation and lecture fees from Nippon Kayaku. Takao Hiraki will receive honoraria for drafting this manuscript from Nippon Kayaku after publication of the article. Jun Koizumi, Yasuo Sakurai, and Hiromitsu Kumada declare that they have no conflicts of interest.

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.

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Hiraki, T., Koizumi, J., Arai, Y. et al. Transcatheter arterial embolization of hypervascular tumors with HepaSphere: prospective multicenter open label clinical trial of microspheres in Japan. Jpn J Radiol 33, 479–486 (2015). https://doi.org/10.1007/s11604-015-0448-8

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11604-015-0448-8

Keywords

Search

Navigation