Gastric Varices Bleeding, Liver Decompensation
Conditions
Keywords
gastric varices bleeding, cyanoacrylate, balloon-occluded retrograde transvenous obliteration, liver decompensation, cirrhosis
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 endoscopic tissue glue injection. The main questions it aims to answer are: * Recurrent gastric variceal bleeding * Further decompensation of liver cirrhosis Participants will receive balloon-occluded retrograde transvenous obliteration and endoscopic tissue glue injection. Researchers will compare balloon-occluded retrograde transvenous obliteration and endoscopic tissue glue injection to see if the rebleeding rate associated with balloon-occluded retrograde transvenous obliteration is lower than that associated with endoscopic tissue glue injection.
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 rebleeding than esophageal varices. Previous studies showed that endoscopic injection of cyanoacrylate was superior to endoscopic variceal ligation in the management of gastric variceal bleeding. Another study showed that transjugular intrahepatic portosystemic shunt had a lower rebleeding rate than endoscopic cyanoacrylate injection. However, transjugular intrahepatic portosystemic shunt (TIPS) is more invasive and carries a risk of development of hepatic encephalopathy and is usually preserved for uncontrolled variceal bleeding. Therefore, endoscopic cyanoacrylate injection is recommended as the treatment of choice for GVB. Balloon-occluded retrograde transvenous obliteration (BRTO) is a new therapy for gastric variceal bleeding. However, BRTO is associated with increased portal pressure and worsening of ascites, hepatohydrothorax, and esophageal varices. There are only a few retrospective studies comparing BRTO and endoscopic cyanoacrylate injection in the prevention of recurrent gastric variceal bleeding.
Interventions
Subjects receive sodium tetradecyl sulfate via balloon-occluded retrograde transvenous obliteration at 3 to 5 days after initial hemostasis of acute gastric variceal bleeding.
DRUGCyanoacrylate
Subjects receive endoscopic cyanoacrylate injection at 3 to 5 days after initial hemostasis of acute gastric variceal bleeding then receive repeated endoscopic cyanoacrylate injection at 1-month intervals until obliteration of gastric varices.
Sponsors
Kaohsiung Veterans General Hospital.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age more than 20 years * a history of liver cirrhosis * acute GOV2 or IGV1 bleeding
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| recurrent gastric variceal bleeding | From date of randomization until the date of first documented recurrent gastric variceal bleeding or date of death from any cause, whichever comes first, assessed up to 100 months | recurrent gastric variceal bleeding after interventions |
| further liver decompensation | From date of randomization until the date of first documented further liver decompensation or date of death from any cause, whichever comes first, assessed up to 100 months | further liver decompensation after intervensions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| recurrent upper gastrointestinal bleeding | From date of randomization until the date of first documented recurrent upper gastrointestinal bleeding or date of death from any cause, whichever comes first, assessed up to 100 months | recurrent upper gastrointestinal bleeding after interventions |
| mortality or liver transplantation | From date of randomization until the date of documented liver transplantation or date of death from any cause, whichever comes first, assessed up to 100 months | mortality or liver transplantation after intervensions |
Countries
Taiwan
Contacts
Primary ContactWen-Chi Chen, M.D
Outcome results
None listed