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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