Liver CirrhosisSLIMNCT03584204
Skeletal Muscle Parameters of Liver Cirrhosis in Non-invasive Imaging and Outcome
An observational study of Liver Cirrhosis, run by University Hospital, Bonn at 3 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- imaging
- How many people
- 400 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Jan 2018to 31 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with liver cirrhosis of any etiology and CT scan available
Who may be able to join
- liver cirrhosis of any etiology
- CT scan available
Who cannot join
- HCC or any malignant disease
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites, 2 recruiting
- Recruiting
University Hospital Bonn
Bonn
Michael Praktiknjo, MD, +49228 28715770, michael.praktiknjo@ukbonn.de
- Recruiting
University of Frankfurt
Frankfurt
Jonel Trebicka, MD, PHD, jonel.trebicka@kgu.de
Italy1 site, 1 recruiting
- Recruiting
Sapienza University of Rome
Roma
Manuela Merli, Prof.
About this study
Official title: Role of Skeletal Muscle Parameters in Imaging Analysis in the Prediction of Outcome in Patients With Liver Cirrhosis
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.
Read the 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.
- Conditions
- Liver Cirrhosis
- Being tested
- imaging
- Keywords
- sarcopenia, cirrhosis, transjugular intrahepatic portosystemic shunt, TIPS, acute-on-chronic liver failure, ACLF
- Medical subject headings
- Liver Cirrhosis, Sarcopenia, Fibrosis, Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imagingDiagnostic test
computed tomography, magnetic resosnance imaging, ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival time
time of survival
Measured: up to 60 months
Secondary outcomes (3)
Time to clinical acute decompensations
time to occurrence of acute decompensations of liver cirrhosis (readmissions, hepatic encephalopathy, bleeding, ascites, hepatorenal syndrome, infections)
Measured: up to 60 months
Time to clinical acute-on-chronic liver failure
acute-on-chronic liver failure according to EASL-CLIF-C definition (grade 1 (best) to 3 (worst)
Measured: up to 60 months
Development of sarcopenia
Assessment of sarcopenia according to EASL-guideline
Measured: up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start1 Jan 2018
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- University of Roma La Sapienza
- Responsible party
- Principal investigator, Michael Praktiknjo, University Hospital, Bonn
- Investigators
- Michael Praktiknjo, MD, Principal investigator, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584204
- Sponsor's protocol ID
- SLIM
- Acronym
- SLIM
- Status last verified
- Oct 2021
- First submitted
- 8 May 2018
- Last updated
- 5 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37586906Faron 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.
PubMed 35492329Queck 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.
PubMed 31644538Praktiknjo 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.
PubMed 30939488
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Skeletal Muscle Parameters in Imaging Analysis in the Prediction of Outcome in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT03584204
- Acronym / sponsor ID
- SLIM / SLIM
- Conditions
- Liver Cirrhosis
- Keywords
- sarcopenia, cirrhosis, transjugular intrahepatic portosystemic shunt, TIPS, acute-on-chronic liver failure, ACLF
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Collaborators
- University of Roma La Sapienza
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 12 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with liver cirrhosis of any etiology and CT scan available
Key inclusion criteria (2 listed)
- liver cirrhosis of any etiology
- CT scan available
Key exclusion criteria (1 listed)
- HCC or any malignant disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| imagingcomputed tomography, magnetic resosnance imaging, ultrasound | Diagnostic test | – |
Primary outcome
Survival time
Time frame: up to 60 months
time of survival
3 secondary outcomes
Time to clinical acute decompensations
Time frame: up to 60 months
Time to clinical acute-on-chronic liver failure
Time frame: up to 60 months
Development of sarcopenia
Time frame: up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Derived from this study: PubMed 37586906Praktiknjo 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.
- Derived from this study: PubMed 35492329Faron 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.
- Derived from this study: PubMed 31644538Queck 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.
- Derived from this study: PubMed 30939488Praktiknjo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Praktiknjo, MD principal investigator
University Hospital, Bonn
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by University Hospital, Bonn at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Praktiknjo, MD (+49228 287 15770, michael.praktiknjo@ukbonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival time (time frame: up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03584204, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.