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TIPS With or Without BCAA

RecruitingNAAges 18 Years - 80 YearsAllUnion Hospital, Tongji Medical College, Huazhong …
NCT07281846 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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,

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age between 18 and 80 years old; 2. Diagnosed with cirrhosis complicated by sarcopenia; 3. Patients admitted due to variceal bleeding or refractory ascites who meet the indications for transjugular intrahepatic portosystemic shunt (TIPS). Exclusion Criteria: 1. Hepatocellular carcinoma and/or other malignant tumors; 2. Severe cardiopulmonary insufficiency; 3. Child-Pugh score \> 13 points; 4. Spontaneous recurrent hepatic encephalopathy (HE); 5. Large spontaneous portosystemic shunt; 6. Sepsis; spontaneous bacterial peritonitis (SBP); 7. Allergy to any component of the study nutritional supplement; 8. 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.
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What it tests

  • The BCAA Group (experimental group) takes oral branched-chain amino acid (BCAA) supplements for 3 months starting after TIPS.
  • The Placebo Group (control group) takes oral placebo for 3 months postoperatively-prepared by an independent third party, the placebo is identical to BCAA supplements in appearance, odor, and packagin
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Where

1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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