Clinical trial NCT03584204: Skeletal Muscle Parameters of Liver Cirrhosis in Non-invasive Imaging and Outcome
Official title: Role of Skeletal Muscle Parameters in Imaging Analysis in the Prediction of Outcome in Patients With Liver Cirrhosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Cirrhosis
Keywords: sarcopenia
cirrhosis
transjugular intrahepatic portosystemic shunt
TIPS
acute-on-chronic liver failure
ACLF
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
Collaborators: name: University of Roma La Sapienza
First posted: 2018-07-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with liver cirrhosis of any etiology and CT scan available

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.

Eligibility criteria: Inclusion Criteria:

* liver cirrhosis of any etiology
* CT scan available

Exclusion Criteria:

* HCC or any malignant disease

Primary outcomes:
measure: Survival time
timeFrame: up to 60 months
Secondary outcomes:
measure: Time to clinical acute decompensations
timeFrame: up to 60 months
measure: Time to clinical acute-on-chronic liver failure
timeFrame: up to 60 months
measure: Development of sarcopenia
timeFrame: up to 60 months
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital Bonn
city: Frankfurt
country: Germany
facility: University of Frankfurt
city: Roma
country: Italy
facility: Sapienza University of Rome
Study officials:
affiliation: University Hospital, Bonn
name: Michael Praktiknjo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Faron A, Abu-Omar J, Chang J, Bohling N, Sprinkart AM, Attenberger U, Rockstroh JK, Luu AM, Jansen C, Strassburg CP, Trebicka J, Luetkens J, Praktiknjo M. Combination of Fat-Free Muscle Index and Total Spontaneous Portosystemic Shunt Area Identifies High-Risk Cirrhosis Patients. Front Med (Lausanne). 2022 Apr 12;9:831005. doi: 10.3389/fmed.2022.831005. eCollection 2022.
citation: Queck A, Thomas D, Jansen C, Schreiber Y, Ruschenbaum S, Praktiknjo M, Schwarzkopf KM, Mucke MM, Schierwagen R, Uschner FE, Meyer C, Claria J, Zeuzem S, Geisslinger G, Trebicka J, Lange CM. Pathophysiological role of prostanoids in coagulation of the portal venous system in liver cirrhosis. PLoS One. 2019 Oct 23;14(10):e0222840. doi: 10.1371/journal.pone.0222840. eCollection 2019.
citation: Praktiknjo M, Clees C, Pigliacelli A, Fischer S, Jansen C, Lehmann J, Pohlmann A, Lattanzi B, Krabbe VK, Strassburg CP, Arroyo V, Merli M, Meyer C, Trebicka J. Sarcopenia Is Associated With Development of Acute-on-Chronic Liver Failure in Decompensated Liver Cirrhosis Receiving Transjugular Intrahepatic Portosystemic Shunt. Clin Transl Gastroenterol. 2019 Apr;10(4):e00025. doi: 10.14309/ctg.0000000000000025.