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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Variceal
• Intervention / Treatment: Procedure: EUS-Guided Precise Disconnection of Varices

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Nanfang Hospital
      • Contact: side Liu; Phone Number: China+13570570426; Email: zkm1002@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Chinese population aged 18-80 years;
2. 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);
3. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EUS-Guided Precise Disconnection of Varices or the Prevention of Gastric Variceal Bleeding.	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.
Experimental: Endoscopic Gastric Variceal Glue Injection for the Prevention of Gastric Variceal Bleeding.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Gastric variceal bleeding within 1 year.	1 year

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: NFEC-2023-454

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No