Trial document





This trial has been registered retrospectively.
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  DRKS00016362

Trial Description

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Title

Non-invasive structure-function assessment of the liver by 2D time-harmonic elastography and the dynamic Liver MAximum capacity (LiMAx) test

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Trial Acronym

LiFuDi

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URL of the Trial

https://seek.lisym.org/projects/6

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Brief Summary in Lay Language

The liver is a complex organ of the human body, which accomplishes manifold vital functions. Liver diseases are thus severe medical situations in which an early diagnosis and treatment are fundamental for survival. A deep understanding of pathophysiological changes during liver disease progressing could help to face these challenges of chronic liver diseases.
One important parameter to take into account when treating patients with liver diseases is liver function which can be estimated by analyzing blood parameters. However, they are influenced by many extrahepatic conditions. Far more precise are for example the so called 13C breath tests. They are able to determine liver function by applying a 13C labeled substrate which is exclusively metabolized in the liver. One of these tests used in clinical routine is the 13C-Methacetin Test (LiMAx). Unfortunately, up to now it is not known how liver function measured with LiMAx changes during disease progression and increasing hepatic fibrosis.
Another important parameter is liver structure. Normally, it can be estimated by touching the liver of the patient. Besides, there are a lot of other techniques to measure what is called liver stiffness. One promising method is time-harmonic ultrasound elastography (THE) which could possibly be used for an early detection of hepatic structural changes, for example fibrosis.
The aim of the study is to examine patients and healthy participants by means of LiMAx and THE to gain mechanistic insights in structural and functional changes of liver parameters during disease progression. Participants are simultaneously examined with LiMAx and THE, as well as blood samples are taken.

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Brief Summary in Scientific Language

Accurate determination of hepatic structure and function and their changes could improve the diagnosis and the treatment of patients with chronic liver diseases. However, the structure-function relationship in the progressing liver diseases remains elusive. The aim of this study is the combined measurement of liver function by the 13C-methacetin Liver MAximum capacity (LiMAx) test and liver stiffness by 2D time-harmonic elastography (THE) to improve non-invasive assessment of liver disease progression.

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Organizational Data

  •   DRKS00016362
  •   2019/01/14
  •   [---]*
  •   yes
  •   Approved
  •   EA1/140/15, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Liver fibrosis, Liver cirrhosis, Hepatocellular carcinoma, Colon carcinoma metastasis, Cholangiocarcinoma
  •   K74 -  Fibrosis and cirrhosis of liver
  •   C22 -  Malignant neoplasm of liver and intrahepatic bile ducts
  •   C78 -  Secondary malignant neoplasm of respiratory and digestive organs
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Interventions/Observational Groups

  •   Patients, scheduled for liver surgery, were included and examined with LiMAx (13C-Methacetin Liver Maximum capacity) and THE (time-harmonic ultrasound elastography), as well as blood samples were drawn. If liver surgery occured in patients, the stage of fibrosis of the liver tissue was estimated.
  •   Healthy control group without any history of liver disease and normal blood parameters, simultaneous determination of liver function with LiMAx and liver stiffness with THE; assessment of serological markers
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

liver function / structure relationship (function assessed at enrollment by the Liver MAximum capacity (LiMAx) test and tissue stiffness by 2D time-harmonic elastography (THE))

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Secondary Outcome

Influence of the bicarbonate kinetic on the result of the LiMAx liver function test

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/10/19
  •   97
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Healthy test person ≥ 18 years old;
Patients ≥ 18 years old admitted to the hospital for liver surgery or liver transplantation;
Participants who gave their written informed consent

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Exclusion Criteria

Patients with history of liver transplantation; Patients with a portosystemic shunt; Patients with a known paracetamol allergy; Patients with known coronary heart disease; Patients with severe infectious disease or fever >38.5°; Patients who are unable to cooperate during the study (e.g. mental dysfunction or drug abuse)

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Addresses

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    • Charité Campus Virchow-Klinikum
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • AG Elastography Charité Universitätsmedizin Berlin
    • Mr.  Prof.  Ingolf  Sack 
    • Chariteplatz 1
    • 10117  Berlin
    • Germany
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    • Chirurgische Klinik Campus Virchow-Klinikum CVK
    • Mr.  Dr. rer. nat.  Tilo  Wuensch 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Chirurgische Klinik Campus Virchow-Klinikum CVK
    • Mr.  Dr. rer. nat.  Tilo  Wuensch 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.