TIPS With or Without BCAA

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.

Conditions

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

Interventions

DIETARY_SUPPLEMENT

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

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• The First Affiliated Hospital of Henan University of Science and Technology

  collaborator OTHER

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

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-15

Primary Completion

2027-11-15

Completion

2027-11-15

Countries

• China

Study Locations