Balloon-occluded Retrograde Transvenous Obliteration Versus Endoscopic Tissue Glue Injection in the Prevention of Recurrent Gastric Variceal Bleeding
Overview
- Phase
- Phase 3
- Intervention
- Sodium tetradecyl sulfate
- Conditions
- Gastric Varices Bleeding
- Sponsor
- Kaohsiung Veterans General Hospital.
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- further liver decompensation
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Wen-Chi Chen
Doctor
Kaohsiung Veterans General Hospital.
Eligibility Criteria
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
Arms & Interventions
Balloon-occluded retrograde transvenous obliteration
Information of drug: 3% sodium tetradecyl sulfate injection Name: Fibro-vein injection Manufacturer: STD Pharmaceutical Products Ltd.
Intervention: Sodium tetradecyl sulfate
Endoscopic cyanoacrylate injection
Information of drug: N-butyl-2-cyanoacrylate Name: Histoacryl blue Manufacturer: Braun, Melsungen, Germany
Intervention: Cyanoacrylate
Outcomes
Primary Outcomes
further liver decompensation
Time Frame: 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
recurrent gastric variceal bleeding
Time Frame: 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
Secondary Outcomes
- 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)
- 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)