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Skeletal Muscle Parameters in Computed Tomography and Outcome in Liver Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03584204
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : October 11, 2018
University of Roma La Sapienza
Information provided by (Responsible Party):
Jonel Trebicka, 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 and MRI will be studied.

Condition or disease Intervention/treatment
Liver Cirrhosis Diagnostic Test: imaging

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Role of Skeletal Muscle Parameters in Computed Tomography Analysis in the Prediction of Outcome in Patients With Liver Cirrhosis
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : July 31, 2025
Estimated Study Completion Date : August 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans Cirrhosis

Intervention Details:
  • Diagnostic Test: imaging
    computed tomography

Primary Outcome Measures :
  1. Survival time [ Time Frame: up to 60 months ]
    time of survival

Secondary Outcome Measures :
  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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with liver cirrhosis of any etiology and CT scan available

Inclusion Criteria:

  • liver cirrhosis of any etiology
  • CT scan available

Exclusion Criteria:

  • HCC or any malignant disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03584204

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Contact: Jonel Trebicka, Prof. +49228 287 15770
Contact: Michael Praktiknjo, MD +49228 287 15770

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University Hospital Bonn Recruiting
Bonn, Germany
Contact: Michael Praktiknjo, MD    +49228 28715770   
Sapienza University of Rome Recruiting
Roma, Italy
Contact: Manuela Merli, Prof.         
Sponsors and Collaborators
University Hospital, Bonn
University of Roma La Sapienza
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Principal Investigator: Jonel Trebicka, Prof. University Hospital, Bonn

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jonel Trebicka, Clinical Professor, University Hospital, Bonn Identifier: NCT03584204    
Other Study ID Numbers: Myosteatosis-Sarco-CT
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases