NCT07855913 · Medanta, The Medicity, India
EUS-Guided Coil and Glue vs Glue Injection for Bleeding Gastric Varices in Cirrhosis
What this study is about
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.
View original scientific 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. 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.
Interventions
PROCEDURE
EUS-guided Coil and Cyanoacrylate Glue Injection
Endoscopic ultrasound (EUS)-guided treatment of gastric varices in which embolization coil(s) are deployed into the target varix through a 19-gauge EUS needle, followed by injection of cyanoacrylate glue and a 5% dextrose flush. The procedure is performed under Doppler guidance to achieve complete obliteration of blood flow within the treated varix. Additional EUS-guided treatment may be performed during follow-up until complete variceal obliteration is achieved.
PROCEDURE
Endoscopic Cyanoacrylate Glue Injection
Conventional endoscopic injection of cyanoacrylate glue into gastric varices using a standard sclerotherapy needle. Following endoscopic localization of the target varix, cyanoacrylate glue is injected to achieve variceal obliteration. Technical success is confirmed by hardening of the treated varix on gentle endoscopic probing. Additional endoscopic glue injection may be performed during follow-up until complete variceal obliteration is achieved.
Primary outcome measures
All cause rebleeding rate
Time frame: Upto 12 months from index intervention
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Orlando, Florida
Collaborators
Orlando Health, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 6, 2026 · Source of record for eligibility and locations