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

Fingerprint

Microspheres
Japan
Clinical Trials
Safety
Neoplasms
Feasibility Studies
Terminology
Abdominal Pain
Fever
Incidence

Keywords

  • HepaSphere
  • Hypervascular tumor
  • Microsphere
  • Transcatheter arterial embolization

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

Cite this

Transcatheter arterial embolization of hypervascular tumors with HepaSphere : prospective multicenter open label clinical trial of microspheres in Japan. / Hiraki, Takao; Koizumi, Jun; Arai, Yasuaki; Sakurai, Yasuo; Kumada, Hiromitsu; Nambu, Yoshihiro; Hori, Shinichi.

In: Japanese Journal of Radiology, Vol. 33, No. 8, 21.08.2015, p. 479-486.

Research output: Contribution to journalArticle

Hiraki, Takao ; Koizumi, Jun ; Arai, Yasuaki ; Sakurai, Yasuo ; Kumada, Hiromitsu ; Nambu, Yoshihiro ; Hori, Shinichi. / Transcatheter arterial embolization of hypervascular tumors with HepaSphere : prospective multicenter open label clinical trial of microspheres in Japan. In: Japanese Journal of Radiology. 2015 ; Vol. 33, No. 8. pp. 479-486.
@article{f4f4bec3b7874bcda0ed5033df27f270,
title = "Transcatheter arterial embolization of hypervascular tumors with HepaSphere: prospective multicenter open label clinical trial of microspheres in Japan",
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).",
keywords = "HepaSphere, Hypervascular tumor, Microsphere, Transcatheter arterial embolization",
author = "Takao Hiraki and Jun Koizumi and Yasuaki Arai and Yasuo Sakurai and Hiromitsu Kumada and Yoshihiro Nambu and Shinichi Hori",
year = "2015",
month = "8",
day = "21",
doi = "10.1007/s11604-015-0448-8",
language = "English",
volume = "33",
pages = "479--486",
journal = "Japanese Journal of Radiology",
issn = "1867-1071",
publisher = "Springer Japan",
number = "8",

}

TY - JOUR

T1 - Transcatheter arterial embolization of hypervascular tumors with HepaSphere

T2 - prospective multicenter open label clinical trial of microspheres in Japan

AU - Hiraki, Takao

AU - Koizumi, Jun

AU - Arai, Yasuaki

AU - Sakurai, Yasuo

AU - Kumada, Hiromitsu

AU - Nambu, Yoshihiro

AU - Hori, Shinichi

PY - 2015/8/21

Y1 - 2015/8/21

N2 - 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).

AB - 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).

KW - HepaSphere

KW - Hypervascular tumor

KW - Microsphere

KW - Transcatheter arterial embolization

UR - http://www.scopus.com/inward/record.url?scp=84939571487&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84939571487&partnerID=8YFLogxK

U2 - 10.1007/s11604-015-0448-8

DO - 10.1007/s11604-015-0448-8

M3 - Article

C2 - 26111877

AN - SCOPUS:84939571487

VL - 33

SP - 479

EP - 486

JO - Japanese Journal of Radiology

JF - Japanese Journal of Radiology

SN - 1867-1071

IS - 8

ER -