Short-Term Safety and Efficacy of Balloon-Occluded Retrograde Transvenous Obliteration Using Ethanolamine Oleate: Results of a Prospective,Multicenter, Single-Arm Trial |
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| Authors: | Masao Kobayakawa Shigehiro Kokubu Shozo Hirota Jun Koizumi Norifumi Nishida Taku Yasumoto Satoshi Mochida Hisashi Hidaka Noriko Tanaka Tsuyoshi Tajima |
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| Affiliation: | 1. Department of Gastroenterology and Hepatology, National Center for Global Health and Medicine, Tokyo, Japan;2. Biostatistics Section, Department of Clinical Research and Informatics, Clinical Science Center, National Center for Global Health and Medicine, Tokyo, Japan;3. Department of Diagnostic Radiology, National Center for Global Health and Medicine, Tokyo, Japan;4. Medical Education Center, Keio University School of Medicine, Tokyo, Japan;5. Institute for Liver Disease Minimal Invasive Treatment and Institute for Endoscopy, Shinyurigaoka General Hospital, Kawasaki, Japan;6. Department of Radiology, Hyogo College of Medicine, Nishinomiya, Japan;7. Department of Diagnostic Radiology, School of Medicine, Tokai University, Isehara, Japan;8. Department of Diagnostic and Interventional Radiology, School of Medicine, Osaka City University, Osaka, Japan;9. Department of Diagnostic Radiology, Toyonaka Municipal Hospital, Toyonaka, Japan;10. Department of Gastroenterology and Hepatology, Saitama Medical University Hospital, Irima-gun, Japan;11. Department of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Japan |
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| Abstract: | 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. |
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| Keywords: | AE adverse event BRTO balloon-occluded retrograde transvenous obliteration CAC Central Adjudication Committee CARTO coil-assisted retrograde transvenous obliteration EO ethanolamine oleate EV esophageal varix FAS full analysis set GRS gastrorenal shunt GVs gastric varices PARTO plug-assisted retrograde transvenous obliteration SAE serious adverse event STS sodium tetradecyl sulfate TIPS transjugular intrahepatic portosystemic shunt |
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