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The impact of trans-jugular intrahepatic portosystemic shunts on muscle mass in chronic liver disease.

The impact of trans-jugular intrahepatic portosystemic shunts on body composition in decompensated cirrhosis: A prospective cohort study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12619000081112
Enrollment
14
Registered
2019-01-21
Start date
2019-05-01
Completion date
2021-10-11
Last updated
2023-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to assess changes in body composition following TIPS procedures in decompensated cirrhosis. Patients already referred for TIPS will be recruited from inpatient and outpatient clinics to participate in an observational study with 6 months of follow up. This aims to comprehensively analyse the changes body composition including lean muscle mass, adipose tissue, muscle strength and performance measures and correlate these with biomarkers of immune function, portal hypertension and muscle regulation.

Interventions

Adult patients with cirrhosis who have been referred for a trans-jugular, intrahepatic portosystemic shunt (TIPS) for clinical indications by their treating physician will be approached for participation in this research study. Baseline measures will be obtained prior to TIPS. These measures will be repeated at 3 months and 6 months after TIPS to assess changes in body composition. The trial will involve 6 months of follow up after TIPS. Enrolment: A single slice from the third lumbar vertebrae

Adult patients with cirrhosis who have been referred for a trans-jugular, intrahepatic portosystemic shunt (TIPS) for clinical indications by their treating physician will be approached for participation in this research study. Baseline measures will be obtained prior to TIPS. These measures will be repeated at 3 months and 6 months after TIPS to assess changes in body composition. The trial will involve 6 months of follow up after TIPS. Enrolment: A single slice from the third lumbar vertebrae will be used for a CT performed prior to TIPS (as part of standard of care). This will be analysed for lean muscle mass, subcutaneous adipose tissue and visceral adipose tissue using dedicated computer software. At each appointment (baseline prior to TIPS, 3 months and 6 months post TIPS) Physical assessments (short Physical performance battery and fried frailty index) and clinical history and examination will also be performed (30 minutes). Patients will undergo blood tests (10minutes) and a test of cognitive function, Stroop Test (10minutes). Prior to undergoing TIPS, patients will have had a CT abdomen performed to assist with TIPS planning as part of standard of care. A single slice of this scan at L3 level will be analysed using dedicated software to estimate lean muscle mass and visceral and subcutaneous adipose tissue. A further L3 single slice CT scan will be performed at 6 months after TIPS to assess for changes in these parameters (15min).

Sponsors

Department of Gastroenterology and Hepatology, Austin Health
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adult patients > 18 years old with a diagnosis of cirrhosis on biochemical, clinical, histological or radiological criteria Referred for TIPS for treatment of complications of portal hypertension Patients who have had a CT abdomen (including the L3 vertebrae) performed 6 weeks prior or within 48 hours of TIPS procedure

Exclusion criteria

TIPS for in patients without confirmed cirrhosis Patients unable to perform physical assessments (including handgrip strength) at the time of TIPS procedure due to reduced conscious state or intubation in intensive care.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026