Clinical Trial

TIPS With or Without BCAA

Recruiting
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Summary
Cirrhosis is a major global cause of morbidity and mortality in chronic liver disease patients, accounting for 2.4% of global deaths in 2019. A 1990-2017 Global Burden of Disease study showed rising cirrhosis-related deaths, bringing heavy health and economic burdens. It often leads to portal hypertension and subsequent complications like ascites, gastroesophageal variceal bleeding (20% 6-week mortality), and hepatic encephalopathy (HE). Transjugular intrahepatic portosystemic shunt (TIPS) is an important treatment for variceal bleeding and refractory ascites per guidelines from EASL, AASLD, and the Chinese Medical Association. Malnutrition affects 20% of compensated and over 50% of decompensated cirrhotic patients; sarcopenia (severe malnutrition) is linked to higher cirrhosis-related complications, impaired quality of life, survival, and poor prognosis in TIPS-treated patients. Thus, concurrent sarcopenia intervention during TIPS may improve outcomes. Baveno VII, EASL, and AASLD guidelines recommend branched-chain amino acid (BCAA) and leucine-rich supplements for decompensated cirrhosis to ensure adequate nitrogen intake. RCT evidence shows BCAAs improve skeletal muscle index (SMI) in cirrhotic patients with sarcopenia and reduce HE risk, but evidence for TIPS-treated patients is lacking. This study aims to compare muscle mass changes and clinical prognosis between TIPS patients with sarcopenia, portal hypertension, and variceal bleeding who receive TIPS with or without BCAA supplements.
Trial Details
NCT Number NCT07281846
Lead Sponsor Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborators: The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital of Henan University of Science and Technology
Conditions BCAA, Cirrhosis, Portal Hypertension Related to Cirrhosis, Sarcopenia, Transjugular Intrahepatic Portosystemic Shunt
Enrollment 164 participants
Start Date 2025-11-15
Primary Completion 2027-11-15 (estimated)
Study Completion 2027-11-15 (estimated)
Updated on ClinicalTrials.gov 2025-12-15