TIPS procedure with or without oral branched-chain amino acids (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
This test will try giving oral BCAA supplements for three months after TIPS in adults with cirrhosis and sarcopenia to see if it improves muscle and clinical outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Academic / other |
| Locations | 1 site (Wuhan) |
| Trial ID | NCT07281846 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–80 with cirrhosis complicated by sarcopenia who are undergoing TIPS for variceal bleeding or refractory ascites are the intended participants.
Not a fit: Patients with active malignancy, severe cardiopulmonary failure, very high Child‑Pugh scores (>13), recurrent spontaneous hepatic encephalopathy, large spontaneous portosystemic shunts, sepsis/SBP, allergies to supplement components, or recent high‑protein/nutritional supplementation are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, adding three months of oral BCAA after TIPS could improve muscle mass, reduce some complications, and enhance quality of life and survival for patients with cirrhosis and sarcopenia.
How similar studies have performed: Prior studies have shown BCAA can improve nutritional status and some hepatic encephalopathy outcomes in cirrhosis, but using peri‑TIPS BCAA specifically for sarcopenia and post‑TIPS outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Wuhan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.