Actively Recruiting
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
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-12-15
164
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
T
The First Affiliated Hospital of Zhengzhou University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Cirrhosis is a serious global health issue causing significant illness and death among patients with chronic liver disease. It often leads to portal hypertension and life-threatening complications such as ascites, variceal bleeding, and hepatic encephalopathy. Transjugular intrahepatic portosystemic shunt (TIPS) is a recommended treatment for variceal bleeding and refractory ascites according to major liver disease guidelines. Malnutrition and sarcopenia (severe muscle loss) are common in cirrhosis and worsen patient outcomes, especially after TIPS treatment. This study aims to evaluate the effects of branched-chain amino acid (BCAA) supplements on muscle mass and clinical outcomes in cirrhotic patients undergoing TIPS. Participants are randomly assigned to one of two groups: the experimental group receives oral BCAA supplements for three months starting after the TIPS procedure, while the control group receives a placebo that looks and tastes the same for the same duration. TIPS is performed using standard techniques with covered stents and may include variceal embolization if needed. The study follows patients for one year to compare muscle improvement and clinical events between groups. During the study, participants undergo assessments including muscle mass measurements and physical performance tests. Researchers also track complications like hepatic encephalopathy, rebleeding, shunt dysfunction, and survival over one year. The study collects data on sarcopenia reversal rates and physical performance scores as primary outcomes. Safety and clinical progress are monitored throughout, with the total participation lasting one year after treatment.
CONDITIONS
Brief Title
TIPS With or Without BCAA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years old
- Diagnosed with cirrhosis complicated by sarcopenia
- Admitted due to variceal bleeding or refractory ascites and eligible for transjugular intrahepatic portosystemic shunt (TIPS) treatment
You will not qualify if you...
- Hepatocellular carcinoma and/or other malignant tumors
- Severe cardiopulmonary insufficiency
- Child-Pugh score greater than 13 points
- Spontaneous recurrent hepatic encephalopathy (HE)
- Large spontaneous portosystemic shunt
- Sepsis or spontaneous bacterial peritonitis (SBP)
- Allergy to any component of the study nutritional supplement
- High-energy and high-protein diet or use of calcium, vitamin D, or protein/amino acid supplements within 3 months prior to the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo transjugular intrahepatic portosystemic shunt (TIPS) placement to treat complications of cirrhosis such as variceal bleeding or refractory ascites.
1 visit (in-person)
Duration - 3 months
Participants take oral branched-chain amino acid (BCAA) supplements or placebo for 3 months following TIPS to improve muscle mass and clinical outcomes related to sarcopenia.
Regular visits during the 3-month supplementation period
Duration - Up to 1 year
Participants are monitored for up to 1 year for muscle mass changes, physical performance, hepatic encephalopathy, variceal rebleeding, shunt function, and survival.
Periodic visits up to 1 year
Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Actively Recruiting
Research Team
Y
Yaowei Bai
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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