TIPS With or Without BCAA
Recruiting now · Not applicable · Has a placebo group
Conditions studied: BCAA, Cirrhosis, Portal Hypertension Related to Cirrhosis, Sarcopenia, Transjugular Intrahepatic Portosystemic Shunt
In brief
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.
Key facts
- Study ID
- NCT07281846
- Run by
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- People needed
- 164
- Starts
- 2025-11-15
- Expected to finish
- 2027-11-15
- Last updated by the study team
- 2025-12-15
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age between 18 and 80 years old;
- Diagnosed with cirrhosis complicated by sarcopenia;
- Patients admitted due to variceal bleeding or refractory ascites who meet the indications for transjugular intrahepatic portosystemic shunt (TIPS).
You may not qualify if…
- Hepatocellular carcinoma and/or other malignant tumors;
- Severe cardiopulmonary insufficiency;
- Child-Pugh score > 13 points;
- Spontaneous recurrent hepatic encephalopathy (HE);
- Large spontaneous portosystemic shunt;
- Sepsis; spontaneous bacterial peritonitis (SBP);
- Allergy to any component of the study nutritional supplement;
- High-energy and high-protein diet or use of calcium supplements, vitamin D supplements, or protein/amino acid supplements within 3 months prior to the study.
Where it is running
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, China (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.