EUS-guided coil and glue vs glue injection for bleeding gastric varices in cirrhosis
Official title: 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
Run by Medanta, The Medicity, India · NCT07855913 · Data updated 2026-11-12
This trial tests whether using endoscopic ultrasound to guide coils plus glue works better than glue alone for stopping bleeding from gastric varices in adults with cirrhosis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Medanta, The Medicity, India Academic / other |
| Locations | 2 sites (Orlando, Florida and 1 other locations) |
| Status | Recruiting |
| Started | September 2026 |
| Main results expected | June 2028 |
| Study ends | June 2028 |
| Registry record updated | October 6, 2026 |
| Trial ID | NCT07855913 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with cirrhosis and portal hypertension presenting with bleeding GOV-2 or IGV-1 gastric varices are eligible.
✕Probably not a fit
Patients with non-cirrhotic portal hypertension, esophageal/other variceal sources of bleeding, or contraindications to endoscopy may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, open-label study compares two endoscopic treatments for bleeding gastric varices in patients with cirrhosis. Participants are assigned 1:1 to receive either EUS-guided coil deployment with cyanoacrylate glue or conventional cyanoacrylate glue injection alone. The primary outcome is all-cause rebleeding within 12 months, with secondary outcomes including technical success and timing of any rebleeding. The trial plans to enroll 158 participants across tertiary centers. The approach leverages EUS to visualize varices and feeding vessels to improve obliteration and potentially reduce complications.
Why it matters
Potential benefit: If successful, patients may experience lower rebleeding rates and fewer procedures needed to control gastric variceal bleeding.
How similar studies have gone: Prior observational data and meta-analyses suggest potential benefits of EUS-guided coil and glue therapy, but high-quality randomized evidence has been limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Medanta The Medicity
Gurgaon, Haryana, India Recruiting -
Orlando Health Orlando Regional Medical Center
Orlando, Florida, United States Not yet recruiting
Study contacts
- Study coordinator: Rajesh Puri, MD
- Email: purirajesh1969@gmail.com
- Phone: +919999411125
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.