Assessment of trans-intestinal cholesterol excretion in patients with total biliary obstruction (TICE-PTC)
- Conditions
- total biliary obstruction1001800810013317
- Registration Number
- NL-OMON34484
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 5
Males and females, aged 18-70 years with a total biliary obstruction and successful placement of a biliary percutaneous transhepatic cholangiographic (PTC) drain.
Main exclusion criteria are: unsuccessful ERCP procedure as the medical indication for PTC-drainage; use of cholesterol-lowering medication; genetic hyperlipoproteinemia: familial hypercholesterolemia, LPL-deficiency, familial dysbeta-lipoproteinemia, familial hypertriglyceridemia; BMI > 30 kg/m2; diabetes mellitus type I and type II; having received an investigational drug in the last 3 months before the screening visit; unable or unwilling to comply with the protocol requirements or deemed by the investigator to be unfit for the study; likely to leave the study before its completion.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Total faecal 13C-cholesterol recovery during four days after a single<br /><br>intravenous dose of 13C-cholesterol. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Biliary 13C-cholesterol recovery during four days after a single intravenous<br /><br>dose of 13C-cholesterol.</p><br>