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Skeletal Muscle Parameters in Computed Tomography and Outcome in Liver Cirrhosis

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ClinicalTrials.gov Identifier: NCT03584204
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
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

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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03584204


Contacts
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Contact: Jonel Trebicka, Prof. +49228 287 15770 jonel.trebicka@ukbonn.de
Contact: Michael Praktiknjo, MD +49228 287 15770 michael.praktiknjo@ukbonn.de

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jonel Trebicka, Clinical Professor, University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT03584204     History of Changes
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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Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases