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Recruiting NCT07855913

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

Conditions: Gastric Varices Bleeding, Cirrhosis

Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 110
Sponsor: Medanta, The Medicity, India

Location: Orlando Health Orlando Regional Medical Center Orlando Florida

Summary

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 at 12 months. Secondary outcomes include technical success, early and late rebleeding, number of treatment sessions required for variceal obliteration, glue volume used, procedure-related adverse events, hepatic decompensation, duration of hospital stay, cost of treatment, and mortality.

Eligibility Criteria

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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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07855913). StuddyBuddy aggregates publicly available trial information.