Mechanism of TIPS to Improve Sarcopenia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial population
Patients diagnosed with cirrhosis and requiring TIPS treatment, willing to participate in this study, and meeting the inclusion and exclusion criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Transjugular Intrahepatic Portosystemic Shunt
Procedure/SurgeryAll patients were treated with Transjugular Intrahepatic Portosystemic Shunt (TIPS).
Treatment groups
132 Participants
are divided into 2 treatment groupsGroup A: Sarcopenia1 intervention
Group B: Non-sarcopenia1 intervention
Trial outcomes
Primary outcomes
1
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)
This endpoint evaluates whether longitudinal changes in circulating FGF21 levels after TIPS have a significant Pearson correlation with changes in skeletal muscle mass. Skeletal muscle mass is quantified by the Skeletal Muscle Index (SMI), which is measured by abdominal Computed Tomography (CT) in the unit of cm²/m² . Serum FGF21 levels are measured by Enzyme-Linked Immunosorbent Assay (ELISA) in the unit of picogram per milliliter (pg/mL). This endpoint is intended to determine the role of FGF21 in TIPS-related improvement of sarcopenia.
Time frame
1 yearSecondary outcomes
1
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)
This outcome measure focuses on the dynamic changes in skeletal muscle strength after TIPS, with handgrip strength as the sole assessment index, measured by an electronic handgrip dynamometer in the unit of kilogram-force (kgf). Serum FGF21 levels are measured by Enzyme-Linked Immunosorbent Assay (ELISA) in the unit of picogram per milliliter (pg/mL). Pearson correlation analysis was used to explore the linear correlation between the dynamic changes in handgrip strength and the dynamic changes in serum FGF21 levels after TIPS, so as to reflect the functional recovery status of skeletal muscle in the dimension of muscle strength.
Time frame
1 year2
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)
This outcome measure focuses on the dynamic changes in physical motor function after TIPS, with gait speed as the sole assessment index, measured by the 6-meter walk test in the unit of meter per second (m/s). Serum FGF21 levels are measured by Enzyme-Linked Immunosorbent Assay (ELISA) in the unit of picogram per milliliter (pg/mL). Pearson correlation analysis was used to explore the linear correlation between the dynamic changes in gait speed and the dynamic changes in serum FGF21 levels after TIPS, so as to reflect the functional recovery status of skeletal muscle in the dimension of physical performance.
Time frame
1 year3
Association between Dynamic Changes in Serum Fibroblast Growth Factor 21 (FGF21) Levels and Overall Survival after Transjugular Intrahepatic Portosystemic Shunt (TIPS)
This endpoint investigates whether longitudinal dynamic changes in serum FGF21 levels have a significant association with the overall survival of patients after TIPS, so as to explore the prognostic value of serum FGF21 levels for the survival outcome of patients after TIPS. Cox proportional hazards regression model will be used to analyze the association between dynamic changes in serum FGF21 levels and overall survival, so as to determine whether dynamic changes in serum FGF21 levels are independent influencing factors of overall survival in patients after TIPS. Serum FGF21 levels are measured by Enzyme-Linked Immunosorbent Assay (ELISA) in the unit of picogram per milliliter (pg/mL). Overall survival is defined as the time from TIPS surgery to all-cause death or the last follow-up, assessed based on clinical follow-up records in the unit of month.
Time frame
1 yearSponsors and contacts
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
Huazhong University of Science and Technology
Sponsor institution
The First Affiliated Hospital of Zhengzhou University
Collaborator
The First Affiliated Hospital of Henan University of Science and Technology
Collaborator
Source ClinicalTrials.gov