TIPS With or Without BCAA

Recruiting · NCT07281846 · Interventional (participants receive a specific treatment) · Lead sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

View the official record on ClinicalTrials.gov →

Hypertension

Interventions studied

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

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.

Who can take part

Age range

18 Years to 80 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

Age between 18 and 80 years old;
Diagnosed with cirrhosis complicated by sarcopenia;
Patients admitted due to variceal bleeding or refractory ascites who meet the indications for transjugular intrahepatic portosystemic shunt (TIPS).

Exclusion criteria

Hepatocellular carcinoma and/or other malignant tumors;
Severe cardiopulmonary insufficiency;
Child-Pugh score \> 13 points;
Spontaneous recurrent hepatic encephalopathy (HE);
Large spontaneous portosystemic shunt;
Sepsis; spontaneous bacterial peritonitis (SBP);
Allergy to any component of the study nutritional supplement;
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.

Where it is running

1 location listed.

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

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →