Investigation of the efficacy and safety of balloon-occluded retrograde transvenous obliteration (BRTO) using monoethanolamine oleate for the treatment of gastric varices
- Conditions
- Gastric varices
- Registration Number
- JPRN-jRCT1090220191
- Lead Sponsor
- Tsuyoshi Tajima
- Brief Summary
The present study demonstrates that BRTO with EO for the treatment of GVs is a clinically effective procedure with many mild to moderate AEs.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of disappearance of gastric varices assessed by the central review committee
- Secondary Outcome Measures
Name Time Method Rate of disappearance of the gastric varices assessed by the investigator<br>Rate of complete thrombosis of the gastric varices<br>Presence or absence of bleeding from the gastric varices<br>Presence or absence of appearance of esophageal varices<br>Presence or absence of worsening of esophageal varices<br>Serum bilirubin level<br>Serum albumin level<br>Blood ammonia level<br>Prothrombin activity level