RecruitingNot ApplicableNCT07281846

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

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Enrollment

164 participants

Start Date

Nov 15, 2025

Study Type

INTERVENTIONAL

Conditions

Sarcopenia Cirrhosis Portal Hypertension Related to Cirrhosis BCAA Transjugular Intrahepatic Portosystemic Shunt

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding branched-chain amino acid (BCAA) supplements to a common liver procedure called TIPS (transjugular intrahepatic portosystemic shunt) helps prevent muscle wasting in patients with liver cirrhosis. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with liver cirrhosis complicated by sarcopenia (significant muscle loss) - You were admitted for variceal bleeding (bleeding from enlarged veins in the esophagus) or severe fluid buildup in the abdomen, and you are a candidate for the TIPS procedure **You may NOT be eligible if...** - You have liver cancer or another malignancy - You have severe heart or lung problems - Your liver function score (Child-Pugh) is greater than 13 - You have recurring episodes of hepatic encephalopathy (confusion caused by liver failure) - You have a serious infection (sepsis or spontaneous bacterial peritonitis) - You are allergic to the study supplement - You have been taking high-protein diets or amino acid supplements in the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTThe BCAA Group (experimental group) takes oral branched-chain amino acid (BCAA) supplements for 3 months starting after TIPS.

This prospective randomized controlled trial (RCT) aims to compare changes in muscle mass and clinical outcomes between sarcopenic cirrhotic patients with portal hypertension and variceal bleeding who undergo transjugular intrahepatic portosystemic shunt (TIPS) plus branched-chain amino acid (BCAA) supplementation versus TIPS plus placebo. Eligible patients are aged 18-75 years, with cirrhosis, sarcopenia (defined by EASL guidelines: L3 skeletal muscle index \[L3-SMI\] \<50 cm²/m² for males, \<39 cm²/m² for females, measured via preoperative abdominal CT), and TIPS eligibility due to variceal bleeding or refractory ascites; exclusions include malignancies, severe cardiopulmonary insufficiency, Child-Pugh score \>13, recurrent hepatic encephalopathy (HE), and prior use of nutrition supplements within 3 months. TIPS is standardized with 8mm covered Viatorr stents, intraoperative variceal embolization if needed, and a postoperative portal pressure gradient (PPG) target of \<12 mmHg or ≥50% base

DIETARY_SUPPLEMENTThe 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

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 packaging to maintain blinding.