Mechanism of TIPS to Improve Sarcopenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transjugular Intrahepatic Portosystemic Shunt.
- Who it may be relevant to
- Registry conditions: Sarcopenia, Mechanism, Cirrhosis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Mechanism of Transjugular Intrahepatic Portosystemic Shunt to Improve Sarcopenia by Down-regulation of FGF21
Overview
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.
Interventions
- Procedure Transjugular Intrahepatic Portosystemic Shunt
All patients were treated with Transjugular Intrahepatic Portosystemic Shunt (TIPS).
Primary outcome measures
- Pearson Correlation between Changes in Serum Fibroblast Growth Factor 21 (FGF21) Levels and Changes in Skeletal Muscle Index (SMI) at 1 Year after Transjugular Intrahepatic Portosystemic Shunt (TIPS) [Time frame: 1 year]
Secondary outcome measures (3)
- Pearson Correlation Analysis between Changes in Handgrip Strength and Dynamic Changes in Serum Fibroblast Growth Factor 21 (FGF21) Levels after Transjugular Intrahepatic Portosystemic Shunt (TIPS) [Time frame: 1 year]
- Pearson Correlation Analysis between Changes in Gait Speed and Dynamic Changes in Serum Fibroblast Growth Factor 21 (FGF21) Levels after Transjugular Intrahepatic Portosystemic Shunt (TIPS) [Time frame: 1 year]
- Association between Dynamic Changes in Serum Fibroblast Growth Factor 21 (FGF21) Levels and Overall Survival after Transjugular Intrahepatic Portosystemic Shunt (TIPS) [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Diagnosed with liver cirrhosis and needing TIPS surgical treatment;
- Aged between 18-80 years old;
- Able to understand and sign the informed consent form and willing to cooperate in completing the examinations and follow-up visits.
Exclusion criteria
- Combination of serious cardiovascular and cerebrovascular diseases (such as acute myocardial infarction, severe heart failure, etc.);
- Suffering from malignant tumors and in the active stage;
- Recent (within 3 months) history of major surgeries or traumas;
- The presence of mental illness or cognitive disorders, which are unable to cooperate with the study;
- Undergoing other special treatments that may affect the results of the study (such as certain specific immune-suppressing agents, hormones, etc.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Taiwan · 1 center
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
Publications
- 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 N PMID 36349684
Identifiers
NCT: NCT06794853 · TIPS improves sarcopenia