title: Transarterial embolization of hypervascular tumors using trisacryl gelatin microspheres (Embosphere): a prospective multicenter clinical trial in Japan.
abstract: OBJECTIVE
  To evaluate the feasibility and safety of transarterial embolization (TAE) using trisacryl gelatin microspheres (TGMs) for hypervascular tumors.
  
  
  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.
  
  
  CONCLUSIONS
  TAE using TGMs was technically feasible and safe for devascularization of hypervascular tumors.
authors.affiliation: Department of Diagnostic and Interventional Radiology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan. osuga@radiol.med.osaka-u.ac.jp.
authors.forename: Keigo
authors.initials: K
authors.lastname: Osuga
authors.affiliation: Department of Radiology, St. Marianna University School of Medicine, Kawasaki, Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Nakajima
authors.affiliation: Department of Radiology, Iwate Medical University, Morioka, Japan.|Department of Diagnostic Radiology, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Miyuki
authors.initials: M
authors.lastname: Sone
authors.affiliation: Department of Diagnostic Radiology, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Yasuaki
authors.initials: Y
authors.lastname: Arai
authors.affiliation: Pharmaceuticals Group, Nippon Kayaku Co. Ltd., Tokyo, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Nambu
authors.affiliation: Department of Radiology, Gate Tower Institute for Image Guided Therapy, Izumisano, Japan.
authors.forename: Shinichi
authors.initials: S
authors.lastname: Hori
mesh_terms: D000180:Acrylic Resins / Q000008:administration & dosage*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004067:Digestive System Neoplasms / Q000098:blood supply / Q000628:therapy*; D004621:Embolization, Therapeutic / Q000379:methods*; D005260:Female; D005780:Gelatin / Q000008:administration & dosage*; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012142:Respiratory Tract Neoplasms / Q000098:blood supply / Q000628:therapy*; D013964:Thyroid Neoplasms / Q000628:therapy*; D016896:Treatment Outcome; D014565:Urogenital Neoplasms / Q000098:blood supply / Q000628:therapy*
chemical_list: D000180:Acrylic Resins; C496735:trisacryl gelatin microspheres; D005780:Gelatin
keywords: Embolic agents; Embosphere; Hypervascular tumors; Transcatheter arterial embolization; Trisacryl gelatin microspheres