Ultrasound-guided precise disconnection of gastric varices versus endoscopic glue injection

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.

This trial will test whether an ultrasound-guided procedure (EUS-SVD) prevents re-bleeding of gastric varices better than standard endoscopic glue injections in adults with high-risk or recent gastric variceal bleeding.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07532915 on ClinicalTrials.gov

What this trial studies

In this randomized, prospective trial participants with high-risk or recent/active gastric variceal bleeding are assigned to receive either EUS-guided selective variceal devascularization (EUS-SVD) or conventional endoscopic gastric variceal obturation (GVO) with glue. Procedures are performed in hospital with planned observation stays (about 5 days for EUS-SVD, 3 days for GVO). The primary outcome is the one-year gastric variceal re-bleeding rate and secondary outcomes include procedure-related adverse events and safety. Investigators will compare re-bleeding and complication rates to determine whether EUS-SVD provides more durable bleeding control than current standard treatment.

Who should consider this trial

Good fit: Adults aged 18–80 years with high-risk gastric varices or active/recent gastric variceal bleeding who prefer endoscopic treatment and can provide informed consent are eligible.

Not a fit: Patients with severe hepatic decompensation (hepatorenal syndrome, advanced encephalopathy, very high bilirubin), multiple organ failure, advanced malignancy, portal/splenic vein thrombosis, significant coagulopathy, prior shunt surgery, or pregnancy are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, EUS-SVD could reduce the chance of re-bleeding and lower the need for repeat emergency care or repeat procedures for patients with gastric varices.

How similar studies have performed: Smaller studies and case series of EUS-guided variceal therapies (coils and glue) have shown promising bleeding control versus glue alone, but large randomized data for EUS-SVD specifically remain limited.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong

• Nanfang Hospital — Guangzhou, Guangdong, China (RECRUITING)

Conditions: Gastric Variceal