IMITS longitudinal study: impact of malnutrition, sarcopenia, and a TIPS insertion on prognosis in liver cirrhosis

Recruiting

Conditions: K74.6
K70.3
Other and unspecified cirrhosis of liver
Alcoholic cirrhosis of liver

Registration Number: DRKS00032173

Lead Sponsor: niversitätsmedizin Rostock, Abteilung für Gastroenterologie und Endokrinologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 140

Inclusion Criteria

confirmed liver cirrhosis
- consent ability

Exclusion Criteria

- Unable or unwilling to attend follow-up appointments or unable to answer questionnaires (lack of mobility, lack of compliance, e.g., due to uncontrolled search disease)
- concomitant disease (COPD GOLD 3 or 4, heart failure NYHA 3 or 4, foreseeable need for major surgery)
- Active tumor disease including HCC (pre-existing malignant tumors or reasonable suspicion (e.g., hepatic lesions LIRADS 3 or 4); curatively treated tumors including HCC with no evidence of recurrence for >3 years and non-melanotic skin cancer are not exclusion criteria)
- Criteria of an ACLF fulfilled
- Diseases affecting musculoskeletal or joint function (e.g., apoplexy with paresis)
- Condition after major amputations
- History of eating disorders (e.g., anorexia nervosa, bulimia)
- Restricted food intake or absorption due to other conditions (e.g., achalasia, feeding via PEG, need for special diets (phenylketonuria), short bowel syndrome)
- Cardiac pacemaker/ defibrillator

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death (of any cause), liver transplantation, unplanned inpatient admission for complications of cirrhosis

Secondary Outcome Measures

Name	Time	Method
In the longitudinal study, various examination procedures (questionnaires, anthropometry, hand grip strength, walking speed, bioelectrical impedance analysis (BIA), clinical chemistry, myokinassays, and MRI imaging in patients with TIPS insertion) for sarcopenia and malnutrition diagnosis will be performed at several measurement time points (study inclusion, after 6, and 12 months). Secondary endpoints include changes in parameters assessed by the methods described.