(Withdrawal) Mechanism of Transjugular Intrahepatic Portosystemic Shunt to Improve Sarcopenia

Not yet recruiting

• Conditions: Sarcopenia; Mechanism; Cirrhosis

• Registration Number: NCT06794853
• Lead Sponsor: Wuhan Union Hospital, China

Brief Summary

Sarcopenia is particularly common in patients with chronic liver disease, especially in patients with decompensated cirrhosis, where the prevalence can be more than 50%. Sarcopenia is an important risk factor for a significant increase in mortality in cirrhotic patients, and is closely associated with a high incidence of complications such as hepatic encephalopathy, ascites, and infections . Recent studies have found that TIPS not only significantly improves clinical symptoms caused by portal hypertension, but may also have a positive effect on skeletal muscle mass and function in patients. Although the effect of TIPS in improving sarcopenia has been preliminarily confirmed, its mechanism is not yet fully understood. Therefore, there is an urgent need to explore the mechanism of action of TIPS to improve sarcopenia and provide guidance for clinical treatment options.

Detailed Description

According to whether the sarcopenia improved or not in patients after TIPS, patients were divided into sarcopenia group and non-sarcopenia group, and the relationship between FGF21 levels and sarcopenia improvement in patients after TIPS was analyzed by analyzing the differences between the two groups. During the follow-up of patients after TIPS, blood samples were collected to test serum FGF21 levels and imaging examinations were performed to assess the improvement of sarcopenia; changes in nutritional status, muscle strength and function indicators were analyzed in the process of sarcopenia improvement; changes in serological indicators were analyzed in the process of sarcopenia improvement, with a focus on the serum FGF21 level; the combination of the serum FGF21 level and the muscle strength and function indicators, and evaluate their value in the prognosis of TIPS.

Study Timeline

• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-01-20
• Study First Posted: 2025-01-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-18
• Study Start: 2025-04-01
• Primary Completion: 2027-12
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

1. Diagnosed with liver cirrhosis and needing TIPS surgical treatment;
2. Aged between 18-75 years old;
3. Able to understand and sign the informed consent form and willing to cooperate in completing the examinations and follow-up visits.

Exclusion Criteria

1. Combination of serious cardiovascular and cerebrovascular diseases (such as acute myocardial infarction, severe heart failure, etc.);
2. Suffering from malignant tumors and in the active stage;
3. Recent (within 3 months) history of major surgeries or traumas;
4. The presence of mental illness or cognitive disorders, which are unable to cooperate with the study;
5. Undergoing other special treatments that may affect the results of the study (such as certain specific immune-suppressing agents, hormones, etc.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in sarcopenia at 1-year follow-up after TIPS creation	1 year	Patients were assessed for changes in sarcopenia at 1-year follow-up after TIPS creation. Changes in nutritional status indicators during the improvement of sarcopenia were analyzed, and muscle strength and function were assessed using dual-energy X-ray absorptiometry (DXA) to measure muscle mass throughout the body and at various sites in conjunction with a grip strength meter and a 6-minute walk test. We analyzed the changes in serological indicators during the improvement of sarcopenia, focusing on serum FGF21 levels.