Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07281846

TIPS With or Without BCAA

Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-12-15

164

Participants Needed

1

Research Sites

104 weeks

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 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.

CONDITIONS

Official 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 meet indications for TIPS
Not Eligible

You will not qualify if you...

  • Presence of hepatocellular carcinoma or other malignant tumors
  • Severe cardiopulmonary insufficiency
  • Child-Pugh score greater than 13 points
  • Spontaneous recurrent hepatic encephalopathy
  • Large spontaneous portosystemic shunt
  • Sepsis or spontaneous bacterial peritonitis
  • Allergy to any component of the study nutritional supplement
  • Use of high-energy/high-protein diet or calcium, vitamin D, protein, or amino acid supplements within 3 months prior to the study

AI-Screening

AI-Powered Screening

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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

CONTACT

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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