Liver Cirrhoses Clinical Trial
Official title:
Hepatic Vein Pressure Gradient(HVPG)-Guided Therapy vs Carvedilol Plus Endotherapy for the Prevention of Esophageal Variceal Rebleeding in Patients With Liver Cirrhosis: A Prospective Randomized Controlled Trial
Variceal bleeding is a major complication of cirrhosis, associated with a hospital mortality
rate of 10%-20%. Surviving patients are at high risk for recurrent hemorrhage. For these
reasons, management should be directed at its prevention. Endoscopic variceal band ligation
(EBL) in combination with non-selective β-blocker (NSBB) therapy is the recommended first
line therapy. Transjugular intrahepatic portosystemic stent-shunt (TIPS) is the most
effective method to prevent rebleeding, however, it is burdened with increased hepatic
encephalopathy and deterioration of liver function in patients with advanced cirrhosis. So
TIPS placement forms an alternative if first line therapy fails.
Hepatic venous pressure gradient (HVPG) is currently the best available method to evaluate
the presence and severity of portal hypertension. Patients who experience a reduction in HVPG
of ≥20% or to <12mmHg in response to drug therapy are defined as 'responders'. The lowest
rebleeding rates are observed in patients on secondary prophylaxis who are HVPG responders. A
recent meta-analysis has demonstrated that combination therapy is only marginally more
effective than drug therapy. This suggests that pharmacological therapy is the cornerstone of
combination therapy. Adding EBL may not be the optimal approach to improve the outcome of
HVPG nonresponders and HVPG non-responders are a special high-risk population that may
benefit from a more aggressive approach, such as an early decision for TIPS. It recently was
shown that TIPS placement within 72 hours after acute bleeding not only prevented recurrent
bleeding but also improved survival. These raise the question of whether ligation together
with NSBB should remain the first choice for elective secondary prophylaxis.
Therefore, the purpose of the study is to compare whether HVPG-guided therapy is superior to
standard combination therapy for the prevention of variceal bleeding in patients with
decompensated cirrhosis.
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