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EUS-Guided Coil and Glue vs Glue Injection for Bleeding Gastric Varices in Cirrhosis

RecruitingNAAges 19 Years - anyAllMedanta, The Medicity, India
NCT07855913 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Gastric variceal bleeding is a life-threatening complication of portal hypertension in patients with cirrhosis and is associated with significant morbidity and mortality. Endoscopic cyanoacrylate glue injection is the current standard treatment; however, recurrent bleeding and procedure-related complications remain important concerns. Endoscopic ultrasound (EUS)-guided coil and cyanoacrylate glue injection has emerged as a promising alternative that may improve variceal obliteration and reduce rebleeding rates. This prospective, randomized, open-label, parallel-group trial will compare EUS-guided coil and cyanoacrylate glue injection with conventional endoscopic cyanoacrylate glue injection in patients with cirrhosis presenting with bleeding gastric varices. A total of 158 participants will be randomized in a 1:1 ratio to either treatment arm. The primary outcome is all-cause rebleeding

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age \> 18 years * Confirmed diagnosis of liver cirrhosis with portal hypertension * Patients presenting with suspected bleed from cardio-fundal varices, specifically classified as gastroesophageal varices type-2 (GOV-2) or isolated gastric varices type-1 (IGV-1) Exclusion Criteria: * Patients experiencing bleeding from esophageal varices (EV) or gastroesophageal varices type-1 (GOV-1) or IGV2 * Patients with non-cirrhotic portal hypertension * Active spurt of blood noted from gastric varices seen on endoscopy * Pregnancy * Patients with refractory shock * Sepsis/ACLF * Platelet count \< 50,000 /mL and International Normalized Rate (INR) \> 2.0 * Contraindication to endoscopy * Not willing to provide consent
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What it tests

  • EUS-guided Coil and Cyanoacrylate Glue Injection
  • Endoscopic Cyanoacrylate Glue Injection
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Where

2 sites
Orlando Health Orlando Regional Medical Center
Orlando, United States
Medanta The Medicity
Gurgaon, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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