Transjugular intrahepatic portosystemic shunt (TIPS): effect on pharmacokinetics
Recruiting
- Conditions
- Cirrhosisscarring of the liver10019654
- Registration Number
- NL-OMON48883
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 11
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
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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary study endpoint is the difference in area under the plasma concentration<br /><br>versus time curve for each drug following the oral administration of the drug<br /><br>cocktail two weeks before TIPS placement, a day after TIPS placement, and<br /><br>twelve weeks after TIPS placement. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints include the difference in the following pharmacokinetics<br /><br>parameters: clearance, volume of distribution, absorption rate, mean residence<br /><br>time and elimination half-life. In addition, we want to assess the effect of<br /><br>TIPS placement on the postprandial levels of bile acids, glucose, insulin,<br /><br>c-peptide, GLP-1, FGF19, C4 and glucagon by MMT.</p><br>