Cirrhosis scarring of the liver
Conditions
Interventions
This study consists of three interventions per patient. Patients will receive a
single oral administration of a drug cocktail two weeks before TIPS placement,
a day after TIPS placement, and twelve
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Liver cirrhosis as documented by liver biopsy or elastography (e.g. Fibroscan > 15 kPa) in combination with usual radiological and biochemical signs. 2. Age > 18 years. 3. Elective indication for TIPS (recurrent tense ascites, recurrent/refractory hepatic hydrothorax, or (recurrent) oesophageal or gastric bleeding treated with endoscopic band ligation (EBL) or endoscopic injection sclerotherapy (EIS) more than 2 weeks prior to screening. 4. Signed informed consent
Exclusion criteria
Exclusion criteria: Absolute contraindications for TIPS placement Child-Pugh score >= 10 MELD score > 20 Serum bilirubin 51 > µmol/L INR > 1.7 Serum creatinine > 185 µmol/L Active drug abuse or alcoholism Overt neurologic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study endpoint is the difference in area under the plasma concentration versus time curve for each drug following the oral administration of the drug cocktail two weeks before TIPS placement, a day after TIPS placement, and twelve weeks after TIPS placement. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the difference in the following pharmacokinetics parameters: clearance, volume of distribution, absorption rate, mean residence time and elimination half-life. In addition, we want to assess the effect of TIPS placement on the postprandial levels of bile acids, glucose, insulin, c-peptide, GLP-1, FGF19, C4 and glucagon by MMT. | — |
Countries
Netherlands
Outcome results
None listed