Abstract
ABSTRACT
Background/Aims
International guidelines recommend initiating transjugular intrahepatic portosystemic shunt (TIPS) placement with an 8‐mm stent. However, there is an evident lack of randomized controlled trials evaluating TIPS diameters
Methods
In this multicenter randomized controlled trial, patients with cirrhosis and relatively small liver were randomized 1:1 to receive TIPS with a 7‐mm (
n
= 92) or 8‐mm (
n
= 92) covered stent to prevent variceal rebleeding. The primary endpoint was the incidence of overt HE after randomization. All‐cause rebleeding, orthotopic liver transplantation (OLT)‐free survival and a composite of these outcomes, were designated as secondary endpoints.
Results
Among the 184 enrolled patients, the predominant etiologies of liver cirrhosis were hepatitis B virus infection (56.0%) and alcohol‐related liver disease (20.7%). Over a median follow‐up of 26.5 months, overt HE occurred in 19 patients (20.7%) in the 7‐mm group and 33 patients (35.9%) in the 8‐mm group. The 2‐year cumulative incidence of overt HE was significantly lower in the 7‐mm group than in the 8‐mm group (21.4% vs. 37.2%,
p
= 0.02). Stent diameter, post‐TIPS portosystemic pressure gradient, pre‐covert HE and MELD‐Na score were identified as independent risk factors for overt HE. The rates of shunt dysfunction were statistically similar between groups (8.7% vs. 8.7%,
p
= 1.0), as were 2‐year rebleeding rates (10.9% vs. 9.8%,
p
= 0.81) and OLT‐free survival rates (91.3% vs. 88.0%,
p
= 0.82).
Conclusions
A 7‐mm covered TIPS demonstrated comparable shunt function to an 8‐mm covered stents, with a significantly lower risk of overt HE. These findings support consideration of 7‐mm TIPS stents for preventing variceal rebleeding in cirrhotic patients with a small liver who are undergoing TIPS.
Trail Registration
ClinicalTrials.gov
, NCT02541825