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A Multicenter, Prospective, Randomized Controlled Study on EUS-Guided Precise Disconnection of Varices Versus Endoscopic Gastric Variceal Glue Injection for the Prevention of Gastric Variceal Bleeding.

NCT07532915 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-04-16

No results posted yet for this study

Summary

The purpose of this clinical trial is to evaluate whether Endoscopic Ultrasound-Guided Selective Variceal Devascularization (EUS-SVD) is effective in preventing the re-bleeding of gastric varices. It will also investigate the safety of EUS-SVD. The main questions it aims to answer are:

Does EUS-SVD lead to a greater reduction in the one-year gastric variceal re-bleeding rate among participants compared to conventional Endoscopic Gastric Variceal Obturation (GVO)?

What medical problems (adverse events) do participants experience when receiving EUS-SVD treatment?

Researchers will compare EUS-SVD with GVO (a currently commonly used first-line treatment method) to see if EUS-SVD can be a superior option for treating gastric varices.

Participants will:

Be randomly assigned to undergo either the EUS-SVD or the GVO procedure.

Receive treatment in the hospital and be hospitalized for observation (approximately 5 days for the EUS-SVD group, 3 days for the GVO group).

Return to the hospital for a follow-up gastroscopy or endoscopic ultrasound examination at 3 months after the procedure.

Receive telephone or outpatient follow-ups at 6 months and 12 months after the procedure to report their health status and any bleeding episodes.

Throughout the study period, record and report any re-bleeding events, need for re-intervention, and other complications.

Conditions

  • Gastric Variceal

Interventions

PROCEDURE

EUS-Guided Precise Disconnection of Varices

EUS-SVD is an advanced, minimally invasive endoscopic interventional technique. It leverages the unique advantages of endoscopic ultrasound to precisely locate and completely block the "source" blood vessels responsible for gastric varices, thereby achieving the goal of preventing and treating bleeding.

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2025-10-22
Primary Completion
2026-11-30
Completion
2026-12-30

Countries

  • China

Study Locations

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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 NCT07532915 on ClinicalTrials.gov