JPRN-jRCT1090220191已完成2 期
Investigation of the efficacy and safety of balloon-occluded retrograde transvenous obliteration (BRTO) using monoethanolamine oleate for the treatment of gastric varices - Phase II study of monoethanolamine oleate for the treatment of gastric varices
Tsuyoshi Tajima0 个研究点目标入组 45 人开始时间: 2014年8月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
研究概览
简要总结
The present study demonstrates that BRTO with EO for the treatment of GVs is a clinically effective procedure with many mild to moderate AEs.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Patient who meets all of the following criteria is allowed to enter the study.
- •1.Patient with gastric varices confirmed on endoscopy (with or without gastrointestinal bleeding)
- •2.Patient who has not undergone BRTO for the treatment of gastric varices
- •3.Patient who has a gastrorenal shunt with the longest diameter not less than 8 mm and the narrowest diameter not larger than 20 mm that was confirmed on the abdominal contrast-enhanced CT scan performed within 30 days prior to the study initiation
- •4.Patient without esophageal varices, or patient with esophageal varices classified as F1 and RC0 according to the criteria for endoscopic findings
- •5.Premenopausal patient who agrees to use an effective contraceptive during the study
- •6.Patient who submitted consent forms
排除标准
- •Patient who conflicts with any one of the following criteria is not eligible for the study.
- •1.Patient who had a liver disease of Child-Pugh class C (10 to 15 points)
- •2.Patient with serum creatinine (Cr) level of ? 1.50 mg/dL within 14 days prior to the study initiation
- •3.Patient who is allergic to monoethanolamin oleate or X-ray contrast agent
- •4.Patient who had a shock index not less than 1 within 14 days prior to the study initiation
- •5.Patient with portal thrombosis or embolization
- •6.Patient with hepatocellular carcinoma whose life expectancy is assumed to be within 1 year
- •7.Patient who received partial splenic embolization (PSE) within 90 days prior to consent
- •8.Patient with serum albumin level less than 2.8 g/dL within 14 days prior to the study initiation
- •9.Patient with multiple organ failure or DIC (disseminated intravascular coagulation)
- •10.Patient with stomach ulcer hemorrhage, duodenal ulcer hemorrhage, or erosive hemorrhage
- •11.Patient with serious cardiac disorder
- •12.Patient with serious pulmonary disorder
- •13.Patient whom an endoscopic examination is considered to be at risk
- •14.Patient who is under treatment of bronchial asthma
- •15.Patient with macroglobulinemia
- •16.Patient with multiple myeloma
- •17.Patient with tetany
- •18.Patient with or suspicious for pheochromocytoma
- •19.Patient who participated in any other clinical study or post-marketing study within 28 days prior to consent
- •20.Patient whose adequately voluntary consent is suspicious from the mental or legal perspective
- •21.Patient whose participation in the study is considered to be inadequate by the investigator
研究者
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