Mechanism of TIPS to Improve Sarcopenia

NCT ID: NCT06794853

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 132 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2027-12-31

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.

Conditions

Sarcopenia; Mechanism; Cirrhosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Transjugular Intrahepatic Portosystemic Shunt

Intervention Type: PROCEDURE

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

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.

Transjugular Intrahepatic Portosystemic Shunt

Intervention Type: PROCEDURE

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

Interventions

Transjugular Intrahepatic Portosystemic Shunt

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

Intervention Type: PROCEDURE

Other Intervention Names

TIPS

Eligibility Criteria

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Henan University of Science and Technology

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Jiacheng Liu

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Wuhan, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Jiacheng Liu Dr.

Role: CONTACT

1946046224@qq.com

18627162379

Facility Contacts

Yaowei Bai

Role: primary

baiyaowei918@163.com

+8618627162379

Role: backup

baiyaowei918@163.com

References

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.

Reference Type: RESULT

PMID: 36349684 (View on PubMed)

Other Identifiers

TIPS improves sarcopenia

Identifier Type: -

Identifier Source: org_study_id