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NCT03584204 Clinical Trial

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

Liver Cirrhosis Clinical Trial

— SLIM  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03584204
Other study ID # SLIM
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date August 31, 2026

Study information
Verified date October 2021
Source University Hospital, Bonn
Contact Michael Praktiknjo, MD
Phone +49228 287 15770
Email michael.praktiknjo@ukbonn.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date August 31, 2026
Est. primary completion date July 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - liver cirrhosis of any etiology - CT scan available Exclusion Criteria: - HCC or any malignant disease

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• imaging
computed tomography, magnetic resosnance imaging, ultrasound

Locations
Country Name City State
Germany University Hospital Bonn Bonn
Germany University of Frankfurt Frankfurt
Italy Sapienza University of Rome Roma

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Bonn University of Roma La Sapienza

Countries where clinical trial is conducted

Germany,  Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survival time time of survival up to 60 months
Secondary Time to clinical acute decompensations time to occurrence of acute decompensations of liver cirrhosis (readmissions, hepatic encephalopathy, bleeding, ascites, hepatorenal syndrome, infections) up to 60 months
Secondary Time to clinical acute-on-chronic liver failure acute-on-chronic liver failure according to EASL-CLIF-C definition (grade 1 (best) to 3 (worst) up to 60 months
Secondary Development of sarcopenia Assessment of sarcopenia according to EASL-guideline up to 60 months
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