EUS-Guided Coil and Glue vs Glue Injection for Bleeding Gastric Varices in Cirrhosis
Key facts
- Where
- Orlando, United StatesSee the site
Where in United States
- Orlando Health Orlando Regional Medical CenterOrlando, United StatesContact: Dr shyam, MDNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Medanta, The Medicity, India
- Trial code
- NCT07855913
- Record updated
- 6 October 2026
- Original description
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.Read full original descriptionShow less
Endoscopic Ultrasound-Guided Coil and Glue Injection Versus Endoscopic Glue Injection in Patients With Cirrhosis and Gastric Variceal Bleed: An Open Label Randomized Controlled Trial
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.
Inclusion: 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: Patients experiencing bleeding from esophageal varices (EV) or gastroesophageal varices type-1 (GOV-1) or IGV2; Patients with non-cirrhotic portal hypertension; Platelet count < 50,000 /mL and International Normalized Rate (INR) > 2.0; Active spurt of blood noted from gastric varices seen on endoscopy; Pregnancy; Patients with refractory shock; Sepsis/ACLF; Contraindication to endoscopy; Not willing to provide consent.