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NCT Number: NCT03584204

Skeletal Muscle Parameters of Liver Cirrhosis in Non-invasive Imaging and Outcome

The principal aim of this study is to analyse L3-SMI (skeletal muscle index) in a cohort of patients with decompensated liver cirrhosis and TIPS (transjugular intrahepatic portosystemic shunt), and compare the prognostic power with TPMT (transverse psoas muscle thickness). Furthermore, the role of myosteatosis, determined in CT by L3-SMI, MRI and ultrasound will be studied.

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Key information

Conditions

Liver Cirrhosis Acute-On-Chronic Liver Failure Atrophy Digestive System Diseases Fibrosis Hepatic Insufficiency Liver Diseases Liver Failure Liver Failure, Acute Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Bonn, Bonn, Germany

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About this study

The principal aim of this study is to analyse L3-SMI (skeletal muscle index) in a cohort of patients with decompensated liver cirrhosis and TIPS (transjugular intrahepatic portosystemic shunt), and compare the prognostic power with TPMT (transverse psoas muscle thickness). Furthermore, the role of myosteatosis, determined in CT by L3-SMI, MRI and ultrasound will be studied.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • liver cirrhosis of any etiology
  • CT scan available

Exclusion criteria

  • HCC or any malignant disease

Treatment and study plan

Imaging

Diagnostic Test

computed tomography, magnetic resosnance imaging, ultrasound

Primary outcomes

  1. Survival time

    Time frame: up to 60 months

    time of survival

Secondary outcomes

  1. Time to clinical acute decompensations

    Time frame: up to 60 months

    time to occurrence of acute decompensations of liver cirrhosis (readmissions, hepatic encephalopathy, bleeding, ascites, hepatorenal syndrome, infections)

  2. Time to clinical acute-on-chronic liver failure

    Time frame: up to 60 months

    acute-on-chronic liver failure according to EASL-CLIF-C definition (grade 1 (best) to 3 (worst)

  3. Development of sarcopenia

    Time frame: up to 60 months

    Assessment of sarcopenia according to EASL-guideline

Study contacts

Contact information is provided by the study sponsor or research team.

Johannes Chang, MD

CONTACT

[email protected]

+49228 287 15770

Michael Praktiknjo, MD

CONTACT

[email protected]

+49228 287 15770

Sponsors and collaborators

Lead sponsor

University Hospital, Bonn

Other

Collaborators

  • University of Roma La Sapienza

Registry information

Official study title

Role of Skeletal Muscle Parameters in Imaging Analysis in the Prediction of Outcome in Patients With Liver Cirrhosis

Acronym: SLIM

Important dates

Study start
2018
Primary completion
2025
Study completion
2026
First posted
Jul 12, 2018
Registry last updated
Oct 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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