TIPS procedure with or without oral branched-chain amino acids (BCAA)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter interventional trial enrolls adults with cirrhosis and sarcopenia who are undergoing transjugular intrahepatic portosystemic shunt (TIPS) for variceal bleeding or refractory ascites. After TIPS, participants are assigned to take either oral BCAA supplements or an identical placebo for three months, with the placebo prepared by an independent party. Study staff will monitor nutritional and muscle measures, complication rates such as hepatic encephalopathy and ascites recurrence, and clinical status during follow-up. The trial tests whether concurrent nutritional support with BCAA around the time of TIPS can improve sarcopenia-related outcomes and post‑TIPS prognosis.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Yaowei Bai
• Email: baiyaowei918@163.com
• Phone: +8618627162379

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.