MedTrace Logo

Efficacy and Safety of Contrast EUS-Guided Tissue Glue/Coil Devascularization vs. BRTO for Preventing Recurrent Gastric Variceal Bleeding

NCT07049146 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2025-07-03

No results posted yet for this study

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.

Conditions

  • Gastric Varices Bleeding

Interventions

PROCEDURE

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.

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.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-30
Primary Completion
2028-01-31
Completion
2028-06-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07049146 on ClinicalTrials.gov