Investigating FGF19's Role in Obstructive Cholestasis
FGF19 in Obstructive Cholestasis: "Unveil the Signal"
This study is trying to see how a protein called FGF19 affects bile salt production in people with obstructive cholestasis to better understand liver health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 81 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Academisch Ziekenhuis Maastricht Academic / other |
| Locations | 1 site (Aachen) |
| Trial ID | NCT05718349 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the role of FGF19 in the regulation of bile salt synthesis and its implications for patients with obstructive cholestasis and related conditions. By analyzing biospecimens from patients undergoing specific surgical procedures, the study seeks to understand how bile salts influence metabolic processes and liver function. The research focuses on the signaling pathways activated by bile salts, particularly the FXR-FGF19 pathway, which is crucial for maintaining bile salt homeostasis. The findings could provide insights into the mechanisms underlying cholestasis and related liver diseases.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 who are undergoing pancreaticoduodenectomy (Whipple procedure) or liver resection.
Not a fit: Patients with jejunostomy, inflammatory bowel disease, or those who are pregnant or planning pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of cholestasis and related liver conditions.
How similar studies have performed: While the specific approach of this study may be novel, previous studies have indicated the importance of bile salts in liver function and metabolism, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing pp Whipple or liver resection * Age \>18 and \<75 years Exclusion Criteria: * Jejunostomy * Lactation, pregnancy and planning of pregnancy * Inflammatory bowel disease * Alcohol or drug abuse within 1 year * Inborn errors of bile salt synthesis * Failure to give informed consent or refusal to store patient data for fifteen years
Where this trial is running
Aachen
- RWTH Aachen — Aachen, Germany (Recruiting)
Study contacts
- Principal investigator: Steven Olde Damink, MD, PhD — Academisch Ziekenhuis Maastricht
- Study coordinator: Steven Olde Damink, MD, PhD
- Email: steven.oldedamink@maastrichtuniversity.nl
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.