TIPS With or Without BCAA

Condition(s) studied

Investigational drug(s) / intervention(s)

The 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

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: 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.

Study 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

Primary outcome measure(s)

• Differences in the sarcopenia reversal rate between the two groups (BCAA and Non-BCAA) — 1 year
  Sarcopenia is defined per the European Association for the Study of the Liver (EASL) clinical practice guidelines: the skeletal muscle index (SMI) is calculated as the ratio of the total cross-sectional area of all skeletal muscles at the third lumbar (L3) level (measured via abdominal CT, unit: cm²) to the square of height (unit: m²), with males having SMI \< 50 cm²/m² and females \< 39 cm²/m² diagnosed as sarcopenic. SMI is measured preoperatively and at 3 and 6 months post-TIPS to determine the reversal rate (proportion of patients no longer meeting sarcopenia criteria), and the difference in this rate between the two groups is compared to evaluate the effect of BCAA supplementation.
• Differences in Short Physical Performance Battery (SPPB) scores between the two groups (BCAA and Non-BCAA) — 1 year
  The SPPB consists of three subtests: balance test, gait speed test, and Chair Stand Test. Each subtest is scored from 0 to 4 points, with a total score ranging from 0 to 12 points-higher scores indicate better physical fitness. The SPPB is assessed preoperatively and at 3 and 6 months post-TIPS to compare changes in physical performance between the BCAA and Non-BCAA groups, reflecting the effect of BCAA supplementation on functional capacity in cirrhotic patients with sarcopenia.

Trial sites (1)

More Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials in China

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