TIPS With or Without BCAA

NCT07281846 | Recruiting DMC

• 1 other identifier: TIPS-BCAA
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief 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; Sarcopenia; Transjugular Intrahepatic Portosystemic Shunt; Portal Hypertension Related to Cirrhosis

Keywords

Transjugular Intrahepatic Portosystemic Shunt; Sarcopenia; Portal Hypertension; Cirrhosis; BCAA

Outcome Measures

Primary Outcomes (2)

• Differences in the sarcopenia reversal rate between the two groups (BCAA and Non-BCAA)

  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.

  1 year

• Differences in Short Physical Performance Battery (SPPB) scores between the two groups (BCAA and Non-BCAA)

  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.

  1 year

Secondary Outcomes (4)

• The cumulative incidence of hepatic encephalopathy (HE) in the two groups (BCAA and Non-BCAA)

  1 year

• The cumulative incidence of death in the two groups (BCAA and Non-BCAA)

  1 year

• The cumulative incidence of Variceal Rebleeding in the two groups (BCAA and Non-BCAA)

  1 year

• The cumulative incidence of Shunt Dysfunction in the two groups (BCAA and Non-BCAA)

  1 year

Study Arms (2)

BCAA Group

EXPERIMENTAL

The BCAA Group (experimental group) takes oral branched-chain amino acid (BCAA) supplements for 3 months starting after surgery.

Dietary Supplement: The BCAA Group (experimental group) takes oral branched-chain amino acid (BCAA) supplements for 3 months starting after TIPS.

Non-BCAA Group

PLACEBO COMPARATOR

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.

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

Interventions

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 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 packaging to maintain blinding.

Non-BCAA Group

The BCAA Group (experimental group) takes oral branched-chain amino acid (BCAA) supplements for 3 months starting after TIPS. DIETARY_SUPPLEMENT

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

BCAA Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead
• The First Affiliated Hospital of Zhengzhou University: collaborator
• The First Affiliated Hospital of Henan University of Science and Technology: collaborator

Study Sites (1)

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

Wuhan, China

RECRUITING

MeSH Terms

Conditions

Fibrosis; Sarcopenia; Hypertension, Portal

Interventions

Control Groups; Odorants

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Central Study Contacts

Yaowei Bai

CONTACT

+8618627162379; baiyaowei918@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study adopts a rigorous double-blind design to reduce bias, with specific implementations as follows: The placebo is prepared by an independent third-party institution not affiliated with the research team, and its appearance, odor, and packaging form are identical to those of the branched-chain amino acid (BCAA) supplement. It contains only inactive pharmaceutical excipients and has undergone safety evaluation, ensuring that the two cannot be distinguished by sensory characteristics; stratified block randomization is used for grouping: an independent third-party statistician generates a random allocation sequence via computer software (with gender and Child-Pugh classification as stratification factors and a dynamically adjusted block length of 4), and prepares sealed opaque envelopes to contain the grouping results. The envelopes are only opened by a research coordinator not involved in outcome assessment to confirm the grouping after the patient signs the informed consent form;
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 15, 2025
• Study Start: November 15, 2025
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): November 15, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

CN (1)