Gastric varices
Conditions
Interventions
Intervention type:DRUG,PROCEDURE
Name of intervention:Monoethanolamin oleate, Balloon-occluded retrograde transvenous obliteration (BRTO)
Dose form / Japanese Medical Device Nomenclature:INJECTION
Rou
Sponsors
Tsuyoshi Tajima
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of disappearance of gastric varices assessed by the central review committee | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of disappearance of the gastric varices assessed by the investigator Rate of complete thrombosis of the gastric varices Presence or absence of bleeding from the gastric varices Presence or absence of appearance of esophageal varices Presence or absence of worsening of esophageal varices Serum bilirubin level Serum albumin level Blood ammonia level Prothrombin activity level | — |
Countries
Japan
Contacts
Public ContactYukie Ando
Center for Clinical Sciences, National Center for Global Health and Medicine
Outcome results
None listed