EUS-Guided Coil and Glue vs Glue Injection for Bleeding Gastric Varices in Cirrhosis
Eligible age
19+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Medanta, The Medicity, India
You may qualify if…
- ✓ 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)
You may not qualify if…
- ✕ 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
Where it's recruiting
Orlando
Source: ClinicalTrials.gov · NCT07855913 · last updated 2026-10-06