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 | Recruiting DMC

• 1 other identifier: NFEC-2023-454
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Gastric variceal bleeding within 1 year.

  1 year

Study Arms (2)

EUS-Guided Precise Disconnection of Varices or the Prevention of Gastric Variceal Bleeding.

EXPERIMENTAL

Procedure: EUS-Guided Precise Disconnection of Varices

Endoscopic Gastric Variceal Glue Injection for the Prevention of Gastric Variceal Bleeding.

EXPERIMENTAL

Procedure: EUS-Guided Precise Disconnection of Varices

Interventions

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.

EUS-Guided Precise Disconnection of Varices or the Prevention of Gastric Variceal Bleeding.; Endoscopic Gastric Variceal Glue Injection for the Prevention of Gastric Variceal Bleeding.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital

Guangzhou, Guangdong, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 16, 2026
• Study Start: October 22, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)