Actively Recruiting
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.
Led by Nanfang Hospital, Southern Medical University · Updated on 2026-04-16
84
Participants Needed
1
Research Sites
62 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chinese population aged 18-80 years
- High-risk gastric varices confirmed by gastroscopy for primary prevention or active bleeding due to gastric varices or history of acute gastric variceal bleeding within the past 1 month for secondary prevention
- Preference for endoscopic treatment and voluntary signing of informed consent form
You will not qualify if you...
- History of secondary preventive treatment for gastric varices or shunt surgery
- Presence of hepatorenal syndrome, hepatic encephalopathy grade III/IV, or severe jaundice (serum bilirubin >10 mg/dl)
- Multiple organ failure or advanced malignant tumors
- Pregnancy, gestation, or lactation
- Suspected splenic vein or portal vein thrombosis
- Coagulation dysfunction, platelet count <50,000/mL or INR 2
- Esophageal stenosis or history of esophageal or gastric surgery
- Deemed unsuitable for the study by physician evaluation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Nanfang Hospital
Guangzhou, Guangdong, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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