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Mechanism of TIPS to Improve Sarcopenia

U

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

Status

Enrolling

Conditions

Cirrhosis
Mechanism
Sarcopenia

Treatments

Procedure: Transjugular Intrahepatic Portosystemic Shunt

Study type

Observational

Funder types

Other

Identifiers

NCT06794853
TIPS improves sarcopenia

Details and patient eligibility

About

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.

Full 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.

Enrollment

132 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Diagnosed with liver cirrhosis and needing TIPS surgical treatment;
  2. Aged between 18-80 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.)

Trial design

132 participants in 2 patient groups

Sarcopenia
Description:
Patients were diagnosed with sarcopenia on the basis of CT-quantified skeletal muscle mass index (SMI) during preoperative TIPS and postoperative follow-up. The European Association for the Study of the Liver clinical practice guidelines were used to determine the threshold value for sarcopenia, and SMI was calculated from the ratio of L3 cross-sectional area to height on CT images; those with \<50 cm²/m² in men and \<39 cm²/m² in women were diagnosed with sarcopenia. Patients with preoperative sarcopenia and 1-year postoperative sarcopenia who were still diagnosed with sarcopenia were in the sarcopenia group.
Treatment:
Procedure: Transjugular Intrahepatic Portosystemic Shunt
Non-sarcopenia
Description:
Patients were diagnosed with sarcopenia on the basis of CT-quantified skeletal muscle mass index (SMI) during preoperative TIPS and postoperative follow-up. The European Association for the Study of the Liver clinical practice guidelines were used to determine the threshold value for sarcopenia, and SMI was calculated from the ratio of L3 cross-sectional area to height on CT images; those with \<50 cm²/m² in men and \<39 cm²/m² in women were diagnosed with sarcopenia. Patients with sarcopenia before TIPS and without sarcopenia 1 year after TIPS were considered the non-sarcopenia group.
Treatment:
Procedure: Transjugular Intrahepatic Portosystemic Shunt

Trial contacts and locations

1

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Central trial contact

Jiacheng Liu Dr.

Data sourced from clinicaltrials.gov

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