Clinical StudyShort-Term Safety and Efficacy of Balloon-Occluded Retrograde Transvenous Obliteration Using Ethanolamine Oleate: Results of a Prospective, Multicenter, Single-Arm Trial

PurposeTo evaluate 90-day outcomes after balloon-occluded retrograde transvenous obliteration (BRTO) with ethanolamine oleate (EO) in patients with gastric varices (GVs).Materials and MethodsAn 8-site prospective single-arm clinical trial was conducted. Patients who had endoscopically confirmed GVs with a gastrorenal shunt were eligible for the study. Overnight BRTO was performed, and efficacy was evaluated by endoscopy and contrast-enhanced computed tomography (CT).ResultsForty-five patients (26 men and 19 women; mean age, 67.8 y) were enrolled. The complete regression rate of GVs based on endoscopic images on day 90 was 79.5% (35 of 44 patients; 95% confidence interval, 64.7%-90.2%). The rate of complete thrombosis of GVs based on contrast-enhanced CT on day 90 was 93.0% (40 of 43 patients; 95% confidence interval, 80.9%-98.5%). One patient experienced 2 events of bleeding from GVs, which was different from the GVs treated with BRTO. Appearance of new esophageal varices (EVs) or worsening of existing EVs occurred in 16 of 45 patients (35.6%). Forty-four of 45 patients (97.8%) experienced adverse events (AEs) related to EO, which included fever in 24 (53.3%), hematuria in 23 (51.1%), hemolysis in 16 (35.6%), back pain in 16 (35.6%), and abdominal pain in 10 (22.2%). One case of moderate to severe ascites (2.3%) was observed on day 90. One case of sepsis was the only serious AE observed in relation to EO.ConclusionsThe present study demonstrates that BRTO with EO for the treatment of GVs is a clinically effective procedure with many mild to moderate AEs.