FGF19 in obstructive cholestasis: unveil the signal
Withdrawn
- Conditions
- Obstructive cholestasis10019654
- Registration Number
- NL-OMON43449
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 81
Inclusion Criteria
Patients undergoing pp Whipple
Age >= 18 and < 75 years old
Exclusion Criteria
Jejunostomy
Lactation, pregnancy and planning of pregnancy
Inflammatory bowel disease
Alcohol or drugs abuse within 1 year
Inborn errors of bile salt synthesis
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the net organ flux of FGF19 across abdominal organs<br /><br>calculated by measuring FGF19 levels in human plasma using an enzyme-linked<br /><br>immuno-sorbent assay (ELISA) in cholestatic versus non-cholestatic patients and<br /><br>drained patients. Human plasma will be obtained during surgery from 7 vessels<br /><br>i) radial artery, ii) mesenteric superior vein, iii) mesenteric inferior vein,<br /><br>iv) renal vein, v) splenic vein, vi) hepatic vein and vii) portal vein to<br /><br>calculate net organ fluxes. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary parameters are expression of genes related to bile salt and FGF19<br /><br>signaling in enterohepatic tissues (liver, jejunum, gallbladder, common bile<br /><br>duct and white adipose tissue), genes implicated in glucose and lipid<br /><br>homeostasis, FGF19 levels in bile, gut microbiota, cholestatic itch and bile<br /><br>salt composition in urine.</p><br>