PMID- 28483304
OWN - NLM
STAT- MEDLINE
DCOM- 20171127
LR  - 20220408
IS  - 1535-7732 (Electronic)
IS  - 1051-0443 (Linking)
VI  - 28
IP  - 8
DP  - 2017 Aug
TI  - Short-Term Safety and Efficacy of Balloon-Occluded Retrograde Transvenous 
      Obliteration Using Ethanolamine Oleate: Results of a Prospective, Multicenter, 
      Single-Arm Trial.
PG  - 1108-1115.e2
LID - S1051-0443(17)30378-0 [pii]
LID - 10.1016/j.jvir.2017.03.041 [doi]
AB  - PURPOSE: To evaluate 90-day outcomes after balloon-occluded retrograde 
      transvenous obliteration (BRTO) with ethanolamine oleate (EO) in patients with 
      gastric varices (GVs). MATERIALS AND METHODS: An 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). RESULTS: Forty-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. CONCLUSIONS: The present study demonstrates that BRTO 
      with EO for the treatment of GVs is a clinically effective procedure with many 
      mild to moderate AEs.
CI  - Copyright (c) 2017 SIR. Published by Elsevier Inc. All rights reserved.
FAU - Kobayakawa, Masao
AU  - Kobayakawa M
AD  - Department of Gastroenterology and Hepatology, National Center for Global Health 
      and Medicine, Tokyo, Japan; Medical Education Center, Keio University School of 
      Medicine, Tokyo, Japan. Electronic address: mkobaya@hosp.ncgm.go.jp.
FAU - Kokubu, Shigehiro
AU  - Kokubu S
AD  - Institute for Liver Disease Minimal Invasive Treatment and Institute for 
      Endoscopy, Shinyurigaoka General Hospital, Kawasaki, Japan.
FAU - Hirota, Shozo
AU  - Hirota S
AD  - Department of Radiology, Hyogo College of Medicine, Nishinomiya, Japan.
FAU - Koizumi, Jun
AU  - Koizumi J
AD  - Department of Diagnostic Radiology, School of Medicine, Tokai University, 
      Isehara, Japan.
FAU - Nishida, Norifumi
AU  - Nishida N
AD  - Department of Diagnostic and Interventional Radiology, School of Medicine, Osaka 
      City University, Osaka, Japan.
FAU - Yasumoto, Taku
AU  - Yasumoto T
AD  - Department of Diagnostic Radiology, Toyonaka Municipal Hospital, Toyonaka, Japan.
FAU - Mochida, Satoshi
AU  - Mochida S
AD  - Department of Gastroenterology and Hepatology, Saitama Medical University 
      Hospital, Irima-gun, Japan.
FAU - Hidaka, Hisashi
AU  - Hidaka H
AD  - Department of Gastroenterology, Kitasato University School of Medicine, 
      Sagamihara, Japan.
FAU - Tanaka, Noriko
AU  - Tanaka N
AD  - Biostatistics Section, Department of Clinical Research and Informatics, Clinical 
      Science Center, National Center for Global Health and Medicine, Tokyo, Japan.
FAU - Tajima, Tsuyoshi
AU  - Tajima T
AD  - Department of Diagnostic Radiology, National Center for Global Health and 
      Medicine, Tokyo, Japan.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20170506
PL  - United States
TA  - J Vasc Interv Radiol
JT  - Journal of vascular and interventional radiology : JVIR
JID - 9203369
RN  - 0 (Contrast Media)
RN  - 0 (Oleic Acids)
RN  - 0 (Sclerosing Solutions)
RN  - U4RY8MRX7C (ethanolamine oleate)
SB  - IM
MH  - Aged
MH  - Balloon Occlusion/adverse effects/*methods
MH  - Contrast Media
MH  - Esophageal and Gastric Varices/diagnostic imaging/*therapy
MH  - Female
MH  - Gastroscopy
MH  - Humans
MH  - Japan
MH  - Male
MH  - Oleic Acids/*therapeutic use
MH  - Prospective Studies
MH  - Sclerosing Solutions/*therapeutic use
MH  - Tomography, X-Ray Computed
MH  - Treatment Outcome
EDAT- 2017/05/10 06:00
MHDA- 2017/11/29 06:00
CRDT- 2017/05/10 06:00
PHST- 2016/11/07 00:00 [received]
PHST- 2017/03/30 00:00 [revised]
PHST- 2017/03/31 00:00 [accepted]
PHST- 2017/05/10 06:00 [pubmed]
PHST- 2017/11/29 06:00 [medline]
PHST- 2017/05/10 06:00 [entrez]
AID - S1051-0443(17)30378-0 [pii]
AID - 10.1016/j.jvir.2017.03.041 [doi]
PST - ppublish
SO  - J Vasc Interv Radiol. 2017 Aug;28(8):1108-1115.e2. doi: 
      10.1016/j.jvir.2017.03.041. Epub 2017 May 6.