Clinical evaluation of transcatheter arterial chemoembolization with 2-day-soluble gelatin sponge particles for hepatocellular carcinoma-comparison with insoluble gelatin sponge particles.

PURPOSE: To compare therapeutic effect, adverse events, and embolized hepatic artery impairment in transcatheter arterial chemoembolization between Lipiodol plus insoluble gelatin sponge particles (Gelpart) and Lipiodol plus 2-day-soluble gelatin sponge particles (2DS-GSPs). MATERIALS AND METHODS: In a single-center, prospective, randomized controlled trial, patients with hepatocellular carcinoma were assigned to the 2DS-GSP group or the Gelpart group. Radiographic response at 3 months per modified Response Evaluation Criteria In Solid Tumors was evaluated as the primary endpoint; secondary endpoints were safety (per Common Terminology Criteria for Adverse Events, version 4.0) within 3 months and hepatic branch artery impairment at the time of repeat chemoembolization (grade 0, no damage; grade I, mild vessel wall irregularity; grade II, overt stenosis; grade III, occlusion of more peripheral branch artery than subsegmental artery; grade IV, occlusion of subsegmental artery). Grade II, III, or IV indicated significant hepatic artery impairment. RESULTS: Thirty-seven patients with 143 nodules were randomized to the 2DS-GSP group and 36 patients with 137 nodules were randomized to the Gelpart group. No significant differences in patient background existed between groups. Target lesion response and overall tumor response in the 2DS-GSP and Gelpart groups were 77.7% versus 76.9% and 78.3% versus 77.8%, respectively, with no significant differences. No significant difference in adverse events existed between groups. Hepatic artery impairment was observed in 5% of patients in the 2DS-GSP group (n = 32) and in 16% in the Gelpart group (n = 33; P< .001). CONCLUSIONS: Transcatheter arterial chemoembolization with 2DS-GSPs resulted in the same therapeutic and adverse effects as chemoembolization with Gelpart while causing significantly less hepatic artery impairment.

Midterm results of endovascular abdominal aortic aneurysm repair: comparison of instruction-for-use (IFU) cases and non-IFU cases.

PURPOSE: To investigate the midterm results of abdominal aortic aneurysm repair (EVAR) and compare the endoleak (EL) and abdominal aortic aneurysm (AAA) prognoses between instruction-for-use (IFU) patients and non-IFU patients. MATERIALS AND METHODS: Of 124 patients (104 men, 20 women; mean age 76.2 years; age range 58-93 years) with AAA who underwent EVAR with the Zenith (68 patients) or Excluder device (56) and were analyzed, 86 were IFU and 38 non-IFU. RESULTS: The mean absorbed dose of radiation exposure was 1907 mGy in the IFU group and 2283 mGy in the non-IFU group (p = 0.013). Thirty-five patients experienced EL: 8 (6.5 %) type I and 27 (21.8 %) type II. Type I ELs were observed in 3 patients in the IFU group (3.5 %) and 5 patients in the non-IFU group (13.2 %). Of the 14 patients with AAA diameter expansion of ≥ 5 mm, 6 (6/86, 7.0 %) belonged to the IFU group and 8 (8/38, 21.1 %) to the non-IFU group (p = 0.027). CONCLUSION: The frequency of AAA expansion ≥ 5 mm was higher in non-IFU patients than in IFU patients. Therefore, careful follow-up is necessary for non-IFU patients rather than IFU patients.