Understanding pancreatic complications after surgery
Interest of Metabolomic and Immune Profiling in the Development of Pancreatic Fistulas After Duodenopancreatectomy
This study is trying to find out what causes complications like pancreatic fistulas and pancreatitis after surgery in patients having pancreatic surgery, by looking at their blood and a small piece of their pancreas.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Besancon Academic / other |
| Locations | 1 site (Besançon) |
| Trial ID | NCT06283160 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify predictive biomarkers and risk factors for pancreatic fistulas and post-pancreatectomy acute pancreatitis in patients undergoing elective pancreaticoduodenectomy. By profiling circulating metabolites and assessing the immune status of patients, the study seeks to enhance understanding of the physiopathology behind these complications. Participants will have a small sample of non-tumoral pancreatic tissue collected during surgery for analysis. The findings could lead to the development of preventive measures for these serious post-surgical complications.
Who should consider this trial
Good fit: Ideal candidates are adult patients scheduled for elective pancreaticoduodenectomy who are affiliated with the French social security system.
Not a fit: Patients undergoing emergency surgery or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention strategies for pancreatic complications after surgery.
How similar studies have performed: While the approach of using metabolomics for this purpose is promising, it is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients scheduled to undergo elective pancreaticoduodenectomy * Non-opposition of the subject to participate in the study. * Affiliated to the French social security system (CMU included). Exclusion Criteria: * Emergent surgery. * Pregnant patients. * Refusal to participate or inability to provide informed consent. * Patient under legal protection (individuals under guardianship by court order).
Where this trial is running
Besançon
- University Hospital of Besançon — Besançon, France (Recruiting)
Study contacts
- Study coordinator: Alexandre DOUSSOT, MD, PhD
- Email: adoussot@chu-besancon.fr
- Phone: +33381668343
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.