Cancerous bile duct blockage - Malignant biliary obstruction
Conditions
Interventions
 
Sponsors
Maastricht Universitair Medisch Centrum +
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: To be eligible for participation in this study, a subject must fulfil all of the following criteria: • Age and Consent: The subject must be 18 years of age or older and must provide in-formed consent. • Clinical Diagnosis: The subject must have a confirmed clinical diagnosis of a malig-nant biliary obstruction (MBO), defined as a blockage of the bile ducts due to a malig-nancy. • Jaundice and Bilirubin Levels: The subject must present with jaundice and have total bilirubin levels exceeding 150 µmol/L, thus indicating severe cholestasis and bile flow obstruction. • Indication for Biliary Drainage: The subject must have a clinical indication for biliary drainage. • Biliary Drainage Procedure: The subject must be a candidate for biliary drainage via endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepat-ic biliary drainage (PTBD), with the procedure including the placement of a biliary stent. Subjects undergoing external drainage are excluded.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Unable to provide informed consent: Patients unable to informed consent due to cognitive or neurological impairments will be excluded. • External Drainage: Patients undergoing external drainage will be excluded. In such cases, bile is diverted externally resulting in depletion of the pool of BAs in enterohepatic circulation, which obscures the study results. • Liver conditions: Patients with severe liver cirrhosis Child-Pugh grades B and C will also be excluded. • Kidney failure: Patients that have an indication for, or are undergoing dialysis will be excluded. • Pregnancy and Lactation: Pregnant or breastfeeding women are often excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: To compare the kinetics of total bilirubin and bile salt normalization in patients with MBO after biliary drainage. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives: To analyse bile acid profiles in serum and urine, measure additional markers associated with BA signalling, correlate BA levels with liver tests and kidney injury parameters. | — |
Countries
Netherlands
Contacts
Public ContactJA Luyten
Maastricht Universitair Medisch Centrum +
Outcome results
None listed