Efficacy of 6-mm and 8-mm transjugular intrahepatic portosystemic shunt for variceal bleeding: a randomized controlled trial

Transjugular intrahepatic portosystemic shunt (TIPS) is associated with an increased incidence of hepatic encephalopathy (HE). We aimed to compare the clinical effectiveness of 6-mm and 8-mm TIPS for secondary prophylaxis of variceal bleeding in patients with cirrhosis who were at risk for HE. This was an investigator-initiated, open-label, single-center, parallel, randomized controlled trial (RCT). Patients with cirrhosis and variceal bleeding were randomly assigned to the 6-mm or the 8-mm covered TIPS groups. The primary endpoint was all-cause rebleeding after 2 years. Between September 20, 2017 and September 17, 2021, 144 patients were enrolled and randomly assigned to either the 6-mm (n = 72) or 8-mm (n = 72) TIPS group. Overall, 24 (33.3%) and 16 (22.2%) patients in the 6-mm and 8-mm groups, respectively, experienced rebleeding. In the 6-mm and 8-mm groups, the cumulative rates of rebleeding were 35.2% and 24.1%, respectively (p = 0.187). The 2-year cumulative incidence of overt hepatic encephalopathy (OHE) was significantly higher in the 8-mm group than in the 6-mm group (42.0% vs. 20.3%, p = 0.009). The 2-year actuarial survival rates were 84.6% in the 6-mm group and 83.0% in the 8-mm group. Among this cohort of patients with cirrhosis who are receiving TIPS for the secondary prevention of variceal bleeding, the use of 6-mm stents results in a higher rate of rebleeding but has similar survival and a significantly lower risk of OHE compared to 8-mm stents.