Balloon-occluded Retrograde Transvenous Obliteration for Gastric Variceal Rebleeding

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaohsiung Veterans General Hospital.
• Treatments: Sodium Tetradecyl Sulfate

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

• absence of gastrorenal shunt