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FGF19 in obstructive cholestasis: unveil the signal

FGF19 in obstructive cholestasis: unveil the signal - FOCUS

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43449
Enrollment
81
Registered
2016-10-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

Obstructive cholestasis

Interventions

None listed

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients undergoing pp Whipple Age >= 18 and

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The main study parameter is the net organ flux of FGF19 across abdominal organs calculated by measuring FGF19 levels in human plasma using an enzyme-linked immuno-sorbent assay (ELISA) in cholestatic versus non-cholestatic patients and drained patients. Human plasma will be obtained during surgery from 7 vessels i) radial artery, ii) mesenteric superior vein, iii) mesenteric inferior vein, iv) renal vein, v) splenic vein, vi) hepatic vein and vii) portal vein to calculate net organ fluxes.

Secondary

MeasureTime frame
Secondary parameters are expression of genes related to bile salt and FGF19 signaling in enterohepatic tissues (liver, jejunum, gallbladder, common bile duct and white adipose tissue), genes implicated in glucose and lipid homeostasis, FGF19 levels in bile, gut microbiota, cholestatic itch and bile salt composition in urine.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)