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

NCT ID: NCT03584204

Last Updated: 2021-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2026-08-31

Brief Summary

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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

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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.

Conditions

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Liver Cirrhosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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imaging

computed tomography, magnetic resosnance imaging, ultrasound

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* liver cirrhosis of any etiology
* CT scan available

Exclusion Criteria

* HCC or any malignant disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role collaborator

University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

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Michael Praktiknjo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Praktiknjo, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bonn

Locations

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University Hospital Bonn

Bonn, , Germany

Site Status RECRUITING

University of Frankfurt

Frankfurt, , Germany

Site Status RECRUITING

Sapienza University of Rome

Roma, , Italy

Site Status RECRUITING

Countries

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Germany Italy

Central Contacts

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Michael Praktiknjo, MD

Role: CONTACT

+49228 287 15770

Johannes Chang, MD

Role: CONTACT

+49228 287 15770

Facility Contacts

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Michael Praktiknjo, MD

Role: primary

+49228 28715770

Jonel Trebicka, MD, PHD

Role: primary

Manuela Merli, Prof.

Role: primary

References

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Praktiknjo M, Zhou T, Krusken M, Jacob T, Sprinkart AM, Nowak S, Kimmann M, Dold L, Chang J, Jansen C, Strassburg CP, Luetkens J, Weismuller TJ. Myosteatosis independently predicts transplant-free survival in patients with primary sclerosing cholangitis. Dig Liver Dis. 2023 Nov;55(11):1543-1547. doi: 10.1016/j.dld.2023.08.037. Epub 2023 Aug 14.

Reference Type DERIVED
PMID: 37586906 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35492329 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31644538 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30939488 (View on PubMed)

Other Identifiers

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SLIM

Identifier Type: -

Identifier Source: org_study_id

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