Comparison of retrograde transvenous obliteration, endoscopic ultrasound-guided coil and glue embolization and beta blockers for primary prophylaxis of high-risk fundal varices in patients with liver cirrhosis: a Multi Centre open-label randomized controlled trial.

Gastric varices (GV) develop in 20% of patients with liver cirrhosis. They are commonly classified based on their anatomical location as per Sarin’s classification into gastroesophageal and isolated gastric varices. As a group, bleeding from gastric varices occurs less frequently than esophageal varices (EV). Every episode of variceal hemorrhage from GV is associated with greater blood loss, higher transfusion requirements and greater mortality as compared to acute variceal bleeding (AVB) from EV. All subtypes of gastric varices do not behave similarly clinically. Gastroesophageal varix type 1 (GOV-1) is the most common subtype of gastric varices identified clinically but is associated with very low rates of bleeding compared to gastroesophageal varices type 2 (GOV-2) and isolated gastric varices type 1 (IGV-1). GOV-2 and IGV-1 have the highest rates of bleeding and are collectively called fundal varices due to their location in the fundus of the stomach. Available literature in GV focuses on the prevention of rebleeding (secondary prophylaxis) after an index AVB, with limited data available on primary prophylaxis of fundal varices.

We propose in this randomized controlled trial to compare the efficacy of endoscopic ultrasound-guided coil embolization with balloon occluded retrograde transvenous obliteration or beta-blockers alone in preventing a first episode of variceal hemorrhage (primary prophylaxis) in patients with liver cirrhosis having fundal varices.