NCT07281846Recruiting
TIPS With or Without BCAA
Transjugular Intrahepatic Portosystemic Shunt With or Without Branched-Chain Amino Acid Supplements in the Treatment of Patients With Cirrhotic Portal Hypertension Complicated by Sarcopenia: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 15 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 164 (estimated)
- First submitted
- 2 Dec 2025
- Start date
- 15 Nov 2025
- Primary completion date
- 15 Nov 2027
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Diseases
- High blood pressure
- NCT number
- NCT07281846
What you commit to
- Study type: Interventional
- Planned participants: 164
- From 15 Nov 2025 to the primary completion date, 15 Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Hepatocellular carcinoma and/or other malignant tumors;
- Severe cardiopulmonary insufficiency;
- Allergy to any component of the study nutritional supplement;
Lab values
- 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.
Other
- Child-Pugh score \> 13 points;
- Spontaneous recurrent hepatic encephalopathy (HE);
- Large spontaneous portosystemic shunt;
- Sepsis; spontaneous bacterial peritonitis (SBP);
Who the study is looking for
- 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).
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.