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
Medanta, The Medicity, India
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.
Description
Gastric varices (GV) are a major complication of portal hypertension in patients with cirrhosis and account for approximately 10-30% of all variceal bleeding episodes. Although less common than esophageal variceal bleeding, gastric variceal hemorrhage is often more severe and is associated with higher transfusion requirements, increased risk of rebleeding, and significant mortality. Endoscopic injection of cyanoacrylate (CYA) glue is currently the standard endoscopic treatment for bleeding gastric varices and has demonstrated high rates of initial hemostasis. However, recurrent bleeding, incom…
Eligibility
- Age range
- 19+ years
- Sex
- All
- Healthy volunteers
- No
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 *…
Interventions
- ProcedureEUS-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.
- ProcedureEndoscopic 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.
Locations (2)
- Orlando Health Orlando Regional Medical CenterOrlando, Florida
- Medanta The MedicityGurgaon, Haryana