Decompensated Cirrhosis Clinical Trial
Official title:
Transjugular Intrahepatic Portosystemic Shunt Versus Endoscopic Treatment Combined With Propranolol for Prevention of Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis: A Randomized Controlled Trial
Portal vein thrombosis (PVT) refers to an obstruction in the trunk of the portal vein. It
can extend downstream to the portal branches, or upstream to the splenic and/or the
mesenteric veins. The prevalence of PVT is 10-25% and incidence is about 16% in cirrhotic
patients. Recent studies demonstrate that the presence of PVT is not only an independent
predictor of failure to control active variceal bleeding and prevent variceal rebleeding,
but also significantly associated with increased mortality in patients with liver cirrhosis.
However, in recent American Association of the Study of Liver Disease (AASLD) practice
guidelines and Baveno V consensus, no treatment strategies in cirrhotic patients with PVT
was clearly recommended due to the absence of randomized controlled trials.
Usually, cirrhotic patients with PVT are submitted to variceal rebleeding prophylaxis with
endoscopic band ligation combined with non-selective beta-blockers and, when necessary, the
anticoagulation is started after the varices eradication.
TIPS is just regarded as the second-line therapy for the secondary prophylaxis of variceal
bleeding in cirrhotic patients. However, this indication might be changed in the setting of
PVT. Indeed, the risk to benefit ratio of TIPS in cirrhotic patients with PVT for the
prevention of recurrent variceal bleeding has never been evaluated.
The aim of this study is to compare the efficacy and safety of TIPS and endoscopic band
ligation + propranolol in decompensated cirrhosis patients with PVT and a history of
variceal bleeding in the past 6 weeks.
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