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 language | English |
|---|---|
| Pages (from-to) | 479-486 |
| Number of pages | 8 |
| Journal | Japanese Journal of Radiology |
| Volume | 33 |
| Issue number | 8 |
| DOIs | |
| Publication status | Published - Aug 21 2015 |
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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 journal › Article
}
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 -