Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07532915

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.

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
84 (estimated)
Sponsor
Nanfang Hospital, Southern Medical University · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREEUS-Guided Precise Disconnection of VaricesEUS-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.

Timeline

Start date
2025-10-22
Primary completion
2026-11-30
Completion
2026-12-30
First posted
2026-04-16
Last updated
2026-04-16

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07532915. Inclusion in this directory is not an endorsement.