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Efficacy and Safety of Contrast EUS-Guided Tissue Glue/Coil Devascularization vs. BRTO for Preventing Recurrent Gastric Variceal Bleeding
Sponsor: West China Hospital
Summary
The goal of this clinical trial is to compare the effectiveness of EUS-guided tissue glue/coil injection and BRTO in preventing rebleeding of gastric varices (GVs) in patients with portal hypertension and GVs (including those with esophageal varices, ascites, or hepatic encephalopathy). The main questions it aims to answer are: Is the 1-year all-cause rebleeding rate of EUS-guided tissue glue/coil injection for GVs non-inferior to that of the BRTO group? Does EUS-guided tissue glue/coil injection differ from BRTO in the incidence of decompensated portal hypertension events (variceal bleeding, overt hepatic encephalopathy, ascites) and survival rate post-treatment? Researchers will compare patients randomized 1:1 to the EUS-guided tissue glue/coil injection arm vs. the BRTO arm to see if there are differences in rebleeding rates and complications. Participants will: Receive EUS-guided tissue glue/coil injection or BRTO. Take carvedilol long-term (if no contraindications) to reduce portal pressure. Undergo follow-up assessments at 1, 3, 6, and 12 months ±7 days.
Official title: Efficacy and Safety of Contrast Endoscopic Ultrasound-Guided Tissue Glue/Coil Devascularization vs. Balloon-Occluded Retrograde Transvenous Obliteration for Preventing Recurrent Gastric Variceal Bleeding: A Prospective Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
242
Start Date
2025-07-30
Completion Date
2028-06
Last Updated
2025-07-03
Healthy Volunteers
No
Conditions
Interventions
EUS-guided tissue glue/coil injection
Under linear array endoscopic ultrasound (EUS), puncture GVs with a 19G/22G needle, deploy coils, and inject 1-2ml tissue glue until blood flow in GVs disappears (or inject glue directly if coils are unsuitable). Treat moderate-to-severe esophageal varices (EVs) with band ligation during or after the procedure.
BRTO
Establish vascular access via the femoral or internal jugular vein, occlude gastrorenal shunts with a balloon catheter, and inject sclerosant foam. Treat moderate-to-severe EVs with band ligation within 5 days post-procedure.
Locations (1)
37 Guoxue Lane
Chengdu, Sichuan, China