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

Recruiting

• Conditions: Liver Cirrhosis

• Registration Number: NCT03584204
• Lead Sponsor: University Hospital, Bonn

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-05-08
• Study First Submitted QC: 2018-07-10
• Study First Posted: 2018-07-12
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-05
• Primary Completion: 2025-07-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• liver cirrhosis of any etiology
• CT scan available

Exclusion Criteria

• HCC or any malignant disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival time	up to 60 months	time of survival

Secondary Outcome Measures

Name	Time	Method
Time to clinical acute-on-chronic liver failure	up to 60 months	acute-on-chronic liver failure according to EASL-CLIF-C definition (grade 1 (best) to 3 (worst)
Time to clinical acute decompensations	up to 60 months	time to occurrence of acute decompensations of liver cirrhosis (readmissions, hepatic encephalopathy, bleeding, ascites, hepatorenal syndrome, infections)
Development of sarcopenia	up to 60 months	Assessment of sarcopenia according to EASL-guideline

Trial Locations

Locations (3)

University Hospital Bonn; 🇩🇪 Bonn, Germany

University of Frankfurt; 🇩🇪 Frankfurt, Germany

Sapienza University of Rome; 🇮🇹 Roma, Italy