A clinical study on the use of porous
gelatin particles(sterile
gelatin embolization material,
YM 670, Gelpart) in transcatheter arterial embolization (TAE) was performed in patients with
hepatocellular carcinoma, and the efficacy (embolization,anti-
tumor effect, recanalization and operationality) and safety (tolerability) were studied. An additive agent comprising porous
gelatin particles and low osmolarity
contrast media was administered peripherally through a
catheter into the hepatic artery proper of 63 patients with
hepatocellular carcinoma. Good hepatic arterial embolization was confirmed in all cases (embolization: 100%), and a
tumor necrosis effect was obtained in most cases (35/62 patients, 56.5%). Moreover, operationality was assessed as "highly easy to use" or "easy to use" in all cases. Frequencies of adverse events in which a relationship to TAE was not excluded and abnormalities of clinical laboratory data were high at 71.4% and 9 8.4%, respectively. The most common adverse reactions were
pyrexia,
abdominal pain, queasiness and blood pressure increase;abnormalities in clinical laboratory data included hepatic function with increased AST (GOT), increased ALT (GPT), decreased
cholinesterase, increased LDH and increased total
bilirubin. These adverse reactions and abnormalities in clinical laboratory data, however, were transient and attributed to the TAE procedure itself, and no adverse reactions related to
YM 670 as an embolic material were observed. In addition, with regard to tolerability (safety), the treatment was assessed as suitable for use in all the present cases.