Gastric Varices
Conditions
Brief summary
The purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection versus balloon-occluded retrograde transvenous obliteration in the prevention of gastric variceal bleeding.
Interventions
Balloon-occluded retrograde transvenous obliteration
PROCEDUREEndoscopic cyanoacrylate injection
Endoscopic cyanoacrylate injection
DRUGLauromacrogol
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Cirrhosis 2. Patients with high risk gastric varices (GOV2 or IGV1) 3. Presence of gastrorenal shunt
Exclusion criteria
1. Acute bleed or past history of bleed from gastric varices 2. Previous treatment of gastric varices. 3. Non-cirrhotic portal hypertension 4. Contraindications to cyanoacrylate injection or BRTO 5. Portal cavernoma 6. Hepatorenal syndrome 7. Proven malignancy including hepatocellular carcinoma 8. End-stage renal disease under renal replacement therapy; 9. Cardiorespiratory failure 10. Pregnancy or patients not giving informed consent for endoscopic procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bleeding rate from gastric varices | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with increase or decrease in the size of gastric varices | 3 years |
| Number of participants with appearance or worsening of new oesophageal varices | 3 years |
| Number of participants with appearance or worsening of portal hypertensive gastropathy | 3 years |
| Number of participants with appearance or worsening of ascites | 3 years |
| Eradication rate of gastric varices | 3 years |
| Average in-hospital stay | 3 years |
| Cost of treatment | 3 years |
| Mortality rate | 3 years |
| Number of participants with complication | 3 years |
Countries
China
Contacts
Primary ContactXufeng Luo, MD
Outcome results
None listed