Mechanism of TIPS to Improve Sarcopenia

Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study ID
NCT06794853
Status
Recruiting
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Conditions

  • Cirrhosis
  • Mechanism
  • Sarcopenia

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Transjugular Intrahepatic Portosystemic Shunt — PROCEDURE
    All patients were treated with Transjugular Intrahepatic Portosystemic Shunt (TIPS).

Study Details

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.

Key Dates

First listed
Jan 27, 2025
Start date
Jun 1, 2025
Status verified
Nov 2025
Primary completion
Dec 1, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
132 participants (estimated)

Arms

  • Arm: Sarcopenia
    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.
  • Arm: Non-sarcopenia
    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.

Primary Outcome Measure

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 ]

Central Contacts

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