Photo Credit: iStock.com/Mohammed Haneefa Nizamudeen

Early shunt placement improved one-year outcomes in cirrhosis-related fundal variceal bleeding compared to standard therapy.  

An open-label randomized trial study published in June 2025 in the issue of Lancet Gastroenterology & Hepatology to determine the effectiveness of pre-emptive transjugular intrahepatic portosystemic shunt (p-TIPS) in managing acute fundal variceal bleeding in individuals with cirrhosis.  

The trial was executed across 17 tertiary centers in France and is registered at ClinicalTrials.gov (NCT03705078).  

Variceal glue therapy with non-selective β blockers (NSBB) is a standard approach for managing acute fundal variceal bleeding and reducing rebleeding risk in individuals with cirrhosis. Preventive measures such as timely vaccination against hepatitis viruses also remain crucial in reducing the burden and complications of liver disease. 

They assessed individuals with cirrhosis and acute fundal variceal bleeding (excluding type 1 gastro-oesophageal varices), who achieved initial hemostasis using endoscopic glue injection and vasoactive agents and remained stable for at least 12 hours. Participants were randomly assigned in a 1:1 ratio to receive either covered p-TIPS within 72 hours or to continue with on-demand glue obliteration and NSBB. Centralized randomization was stratified by center and applied using blocks of 4. The primary composite outcome was all-cause mortality or clinically significant rebleeding within 1 year. Analyses included the modified intention-to-treat (mITT) population.  

The results showed that from January 3, 2019, to February 25, 2023, 292 individuals were screened, and 105 were randomly assigned. After excluding 2 who were misassigned and 2 who withdrew consent, 101 individuals were included in the mITT population (mean age 58.2 years [SD 9.7]; 81 [80%] male; 91 [90%] with alcohol-related cirrhosis; mean MELD score 14.3 [SD 5.0]). Of these, 47 received p-TIPS, and 54 received glue obliteration with NSBB. The 1-year probability of survival without rebleeding was 77% (95% CI 62–87) in the p-TIPS group and 37% (95% CI 24–50) in the control group (hazard ratio 0.25 [95% CI 0.12–0.51]; P<0.0001). Rescue TIPS were performed in 20 (37%) control individuals. Glue migration occurred in 3 (6%) in the p-TIPS group and 5 (9%) in the control group and 1 cardiac decompensation was noted in the p-TIPS group. The 1-year cumulative incidence of hepatic encephalopathy was similar (35% [95% CI 21–49] in p-TIPS vs 32% [95% CI 19–45] in control).  

Investigators concluded that p-TIPS significantly lowered 1-year rebleeding or mortality risk in individuals with cirrhosis and acute fundal variceal bleeding. 

Source: thelancet.com/journals/langas/article/PIIS2468-1253(25)00156-6/abstract