Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID07281846

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

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)

Treatment

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

Follow-up

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

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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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