TIPS With or Without BCAA

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

Status: Enrolling

Conditions: BCAA; Transjugular Intrahepatic Portosystemic Shunt; Cirrhosis; Sarcopenia; Portal Hypertension Related to Cirrhosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07281846

TIPS-BCAA

Details and patient eligibility

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.

Full description

Cirrhosis is a major cause of morbidity and mortality among patients with chronic liver disease worldwide. In 2019, cirrhosis accounted for 2.4% of global deaths. A Global Burden of Disease study (1990-2017) showed that the number of deaths caused by cirrhosis has been on the rise year by year since 1990, imposing a severe health and economic burden on many countries and peoples around the world. Cirrhosis is usually accompanied by the development of portal hypertension, which further leads to complications such as ascites, gastroesophageal variceal bleeding, and hepatic encephalopathy (HE). Among these, the mortality rate of gastroesophageal variceal bleeding reaches as high as 20% within 6 weeks of onset. Currently, according to guidelines issued by the European Association for the Study of the Liver (EASL), the American Association for the Study of Liver Diseases (AASLD), and the Chinese Medical Association, transjugular intrahepatic portosystemic shunt (TIPS) has become an important treatment for variceal bleeding and refractory ascites.

Malnutrition is a common complication of cirrhosis, affecting 20% of patients with compensated cirrhosis and more than 50% of those with decompensated cirrhosis. Sarcopenia is generally regarded as severe malnutrition, and its occurrence is often associated with a higher risk of cirrhosis-related complications (such as hepatic encephalopathy, ascites, and infections), which seriously impairs patients' quality of life and survival. Several studies have shown that sarcopenia is associated with poor prognosis in cirrhotic patients undergoing TIPS treatment. Therefore, concurrent intervention for sarcopenia during TIPS treatment may improve prognosis and thus enhance patient survival.

The Baveno VII guidelines point out that malnutrition increases the risk of poor prognosis in patients with cirrhosis and acute variceal bleeding, and oral nutrition should be initiated as soon as possible. Both the EASL Clinical Practice Guidelines on Nutrition in Chronic Liver Disease and the AASLD Practice Guidance on Malnutrition, Frailty, and Sarcopenia in Patients with Cirrhosis recommend the use of branched-chain amino acid (BCAA) supplements and leucine-rich amino acid supplements in patients with decompensated cirrhosis to achieve adequate nitrogen intake. An RCT study demonstrated that BCAA supplements can improve the skeletal muscle index (SMI) in cirrhotic patients with sarcopenia. Additionally, evidence suggests that BCAA supplements can significantly reduce the risk of hepatic encephalopathy (HE).

Therefore, BCAA supplements may serve as a routine nutritional supplement for cirrhotic patients undergoing TIPS treatment, but relevant evidence is currently lacking. This study aims to compare changes in muscle mass and clinical prognosis between cirrhotic patients with portal hypertension and variceal bleeding complicated by sarcopenia who receive TIPS with or without BCAA supplements, so as to verify our hypothesis.

Enrollment: 164 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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164 participants in 2 patient groups, including a placebo group

BCAA Group

Experimental group

Description:

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

Treatment:

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 group

Description:

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.

Treatment:

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