Ultrasound-guided precise disconnection of gastric varices versus endoscopic glue injection
Official title: 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.
Run by Nanfang Hospital, Southern Medical University · NCT07532915 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 84 (estimated) |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | October 22, 2025 |
| Main results expected | November 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | April 16, 2026 |
| Trial ID | NCT07532915 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Nanfang Hospital
Guangzhou, Guangdong, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.