EUS-Guided Coil and Glue vs Glue Injection for Bleeding Gastric Varices in Cirrhosis

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• All cause rebleeding rate — Upto 12 months from index intervention

Trial sites (2)

More Medanta, The Medicity, India trials in India

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