NCT03584204

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
2 countries

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jan 2018Aug 2026

Study Start

First participant enrolled

January 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 12, 2018

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

October 5, 2021

Status Verified

October 1, 2021

Enrollment Period

7.6 years

First QC Date

May 8, 2018

Last Update Submit

October 4, 2021

Conditions

Liver Cirrhosis

Keywords

sarcopeniacirrhosistransjugular intrahepatic portosystemic shuntTIPSacute-on-chronic liver failureACLF

Outcome Measures

Primary Outcomes (1)

  • Survival time

    time of survival

    up to 60 months

Secondary Outcomes (3)

  • Time to clinical acute decompensations

    up to 60 months

  • Time to clinical acute-on-chronic liver failure

    up to 60 months

  • Development of sarcopenia

    up to 60 months

Interventions

imagingDIAGNOSTIC_TEST

computed tomography, magnetic resosnance imaging, ultrasound

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with liver cirrhosis of any etiology and CT scan available

You may qualify if:

  • liver cirrhosis of any etiology
  • CT scan available

You may not qualify if:

  • HCC or any malignant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospital Bonn

Bonn, Germany

RECRUITING

University of Frankfurt

Frankfurt, Germany

RECRUITING

Sapienza University of Rome

Roma, Italy

RECRUITING

Related Publications (4)

  • 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.

    PMID: 37586906DERIVED

  • 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.

    PMID: 35492329DERIVED

  • 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.

    PMID: 31644538DERIVED

  • 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.

    PMID: 30939488DERIVED

MeSH Terms

Conditions

Liver CirrhosisSarcopeniaFibrosisAcute-On-Chronic Liver Failure

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and SymptomsLiver Failure, AcuteLiver FailureHepatic Insufficiency

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Michael Praktiknjo, MD

    University Hospital, Bonn

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Praktiknjo, MD

CONTACT

+49228 287 15770michael.praktiknjo@ukbonn.de

Johannes Chang, MD

CONTACT

+49228 287 15770johannes.chang@ukbonn.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 8, 2018

First Posted

July 12, 2018

Study Start

January 1, 2018

Primary Completion

July 31, 2025

Study Completion (Estimated)

August 31, 2026

Last Updated

October 5, 2021

Record last verified: 2021-10

Locations

IT(1)DE(2)