Status:
UNKNOWN
Balloon-occluded Retrograde Transvenous Obliteration for Gastric Variceal Rebleeding
Lead Sponsor:
Kaohsiung Veterans General Hospital.
Conditions:
Gastric Varices Bleeding
Liver Decompensation
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The goal of this randomized controlled trial is to compare the rebleeding rate in cirhotic patients with gastric variceal bleeding receiving balloon-occluded retrograde transvenous obliteration and en...
Detailed Description
Variceal bleeding is a severe complication of portal hypertension. Gastric variceal bleeding (GVB) is more severe than bleeding from esophageal varices. Gastric varices also have a higher risk of rebl...
Eligibility Criteria
Inclusion
- age more than 20 years
- a history of liver cirrhosis
- acute GOV2 or IGV1 bleeding
Exclusion
- previous treatment for gastric varices, including endoscopic therapy, transjugular intrahepatic portosystemic shunt, or shunt surgery
- hepatocellular carcinoma or other malignancy
- stroke, uremia, or active sepsis
- serum total bilirubin \>10 mg/dL
- grade III/IV hepatic encephalopathy
- refractory ascites
- uncontrolled index bleeding
- pregnancy
- severe heart failure (NYHA Fc III/IV)
- allergy to cyanoacrylate, lipiodol, iodine, or sodium tetradecyl sulfate
- absence of gastrorenal shunt
Key Trial Info
Start Date :
June 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT06106971
Start Date
June 28 2018
End Date
June 1 2025
Last Update
October 30 2023
Active Locations (1)
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1
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan, 813