Prospective Phase II trial of drug-eluting bead chemoembolization for liver transplant candidates with hepatocellular carcinoma and marginal hepatic reserve.

Purpose: To determine whether chemoembolization using drug-eluting beads (DEB-TACE) is safe and effective for liver transplantation candidates with liver-limited hepatocellular carcinoma (HCC) without vascular invasion and baseline hepatic dysfunction. Materials and methods: Seventeen adult liver transplantation candidates (median age 66 years, range 58-73 years; 13 men) with HCC were treated with DEB-TACE as a part of Stage 1 of a prospective single-institution Phase II trial. All patients had marginal hepatic reserve based on at least one of the following criteria: ascites (n=14), bilirubin between 3 and 6 mg/dL (n=5), AST 5-10 times upper normal limit (n=1), INR between 1.6 and 2.5 (n=4), portal vein thrombosis (n=2), and/or portosystemic shunt (n=2). Primary study objectives were safety and best observed radiographic response. Results: Thirty-seven DEB-TACE procedures were performed. Objective response rate and disease control rate were 63% and 88%, respectively. HCC progression was observed in 12 patients. Median time to progression was 5.6 months (range 0.9-13.6 months). Within 1 month following DEB-TACE, 13 patients (76%) developed grade 3 or 4 AE attributable to the procedure. Four patients (all within Milan Criteria) were transplanted (2.7-6.9 months after DEB-TACE), and 12 patients died (1.8-32 months after DEB-TACE). All deaths were due to liver failure that was either unrelated to HCC (n=5), in the setting of metastatic HCC (n=5), or in the setting of locally advanced HCC (n=2). Mortality rate at 1 month was 0%. Conclusions: DEB-TACE achieves tumor responses but carries a high risk of hepatotoxicity for liver transplant candidates with HCC and marginal hepatic reserve

The rationale, design, and methods of a randomized, controlled trial to evaluate the efficacy of single-dose dexamethasone in reducing post-embolization syndrome in patients undergoing uterine artery embolization

Background: Uterine artery embolization (UAE) is a minimally invasive technique well established for treating symptomatic uterine fibroids. However, the post-procedure recovery for UAE involves a notable inflammatory process in response to ischemia known as post-embolization syndrome (PES). PES encompasses transient leukocytosis, low-grade fever, and can result in readmission of up to 10% of patients. In surgical settings, multiple studies have demonstrated the efficacy of glucocorticoids in reducing inflammation and associated pain. However, this approach has not yet been assessed in predominantly ischemia-driven PES. Methods: This paper describes the protocol of a prospective randomized, double-blind, placebo-controlled, multi-center trial to test the efficacy and safety of single-dose dexamethasone on inflammatory responses, pain, nausea, and readmission rates after UAE. The study will enroll pre-menopausal patients between 25 and 55 years (planned enrollment, n = 60) with MRI confirmed symptomatic fibroids. Patients will be randomly allocated into two groups: single-dose intravenous dexamethasone plus standard of care or placebo (normal saline) plus standard of care. Results: The primary endpoint is the patient pain score 4 h following the UAE procedure. Secondary endpoints include pain scores at 7 h and 24 h following UAE; narcotic usage in the first 24 h following UAE; and serum inflammatory markers (white blood cell count, C-reactive protein [CRP], interleukin-6 [IL-6], and cortisol) 24 h after UAE. Conclusion: Given the high incidence of post-procedure pain and difficulty with pain control after uterine artery embolization, results of this trial may directly influence the standard of care in perioperative management of patients undergoing UAE. Keywords: Uterine artery embolization, Post-embolization syndrome, Perioperative, Dexamethasone, Interventional radiolog