Assessment of trans-intestinal cholesterol excretion in patients with total biliary obstruction (TICE-PTC)

Assessment of trans-intestinal cholesterol excretion in patients with total biliary obstruction (TICE-PTC) - TICE-PTC

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON34484

Enrollment

Registered

2010-07-05

Start date

2010-05-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

total biliary obstruction

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Males and females, aged 18-70 years with a total biliary obstruction and successful placement of a biliary percutaneous transhepatic cholangiographic (PTC) drain.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Total faecal 13C-cholesterol recovery during four days after a single intravenous dose of 13C-cholesterol.	—

Secondary

Measure	Time frame
Biliary 13C-cholesterol recovery during four days after a single intravenous dose of 13C-cholesterol.	—

Countries

Netherlands

Outcome results