Recruiting

NCT Number: NCT07532915

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.

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.

Recruiting

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Key information

Conditions

Gastric Variceal

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanfang Hospital

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

side Liu

CONTACT

[email protected]

China+13570570426

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Chinese population aged 18-80 years;
High-risk gastric varices confirmed by gastroscopy (for primary prevention) or active bleeding due to gastric varices or a history of acute gastric variceal bleeding within the past 1 month (for secondary prevention);
Subjects who prefer endoscopic treatment and voluntarily sign the informed consent form.

Exclusion criteria

(1) Subjects with a history of secondary preventive treatment for gastric varices or shunt surgery; (2) Subjects complicated with hepatorenal syndrome, hepatic encephalopathy grade III/IV, or severe jaundice (serum bilirubin >10 mg/dl); (3) Subjects complicated with multiple organ failure or advanced malignant tumors; (4) Subjects who are pregnant, in gestation, or lactating; (5) Subjects suspected of having splenic vein or portal vein thrombosis; (6) Subjects with coagulation dysfunction, platelet count <50,000/mL or INR ≥2; (7) Subjects with esophageal stenosis or a history of esophageal or gastric surgery; (8) Subjects deemed unsuitable for this study by physician evaluation.

Treatment and study plan

EUS-Guided Precise Disconnection of Varices

Procedure

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.

Primary outcomes

Gastric variceal bleeding within 1 year.

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Apr 16, 2026
Registry last updated: Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.