Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07532915

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Nanfang Hospital

Guangzhou, Guangdong, China

Actively Recruiting

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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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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. | DecenTrialz