Clinical trial NCT06794853: (Withdrawal) Mechanism of Transjugular Intrahepatic Portosystemic Shunt to Improve Sarcopenia
Official title: (Withdrawal) Mechanism of Transjugular Intrahepatic Portosystemic Shunt to Improve Sarcopenia by Down-regulation of FGF21
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sarcopenia
Mechanism
Cirrhosis
Keywords: sarcopenia
cirrhosis
FGF21
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with cirrhosis and requiring TIPS treatment, willing to participate in this study, and meeting the inclusion and exclusion criteria.

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Changes in sarcopenia at 1-year follow-up after TIPS creation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Zanker J, Sim M, Anderson K, Balogun S, Brennan-Olsen SL, Dent E, Duque G, Girgis CM, Grossmann M, Hayes A, Henwood T, Hirani V, Inderjeeth C, Iuliano S, Keogh J, Lewis JR, Lynch GS, Pasco JA, Phu S, Reijnierse EM, Russell N, Vlietstra L, Visvanathan R, Walker T, Waters DL, Yu S, Maier AB, Daly RM, Scott D. Consensus guidelines for sarcopenia prevention, diagnosis and management in Australia and New Zealand. J Cachexia Sarcopenia Muscle. 2023 Feb;14(1):142-156. doi: 10.1002/jcsm.13115. Epub 2022 Nov 9.