Actively Recruiting
Interest of Metabolomic and Immune Profiling in the Development of Pancreatic Fistulas After Duodenopancreatectomy
Led by Centre Hospitalier Universitaire de Besancon · Updated on 2024-10-15
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating complications that can occur after pancreatoduodenectomy, a common surgery for treating pancreatic lesions. The study aims to identify biomarkers and risk factors for pancreatic fistula (PF) and postpancreatectomy acute pancreatitis (PPAP) by analyzing the body's metabolites and immune status. This observational research seeks to improve understanding of these complications to help develop preventive strategies. Adult patients scheduled for elective pancreatoduodenectomy will participate without changes to their usual surgical care. During surgery, a small piece of non-tumoral pancreatic tissue will be collected and frozen for metabolomic analysis. Additionally, four blood samples will be taken at specific times: before surgery, and then 7 days, 1 month, and 3 months after surgery to assess the immune response. Participants will be monitored during hospitalization and for up to 3 months afterward to track the occurrence of significant pancreatic fistulas or acute pancreatitis after surgery. Researchers will evaluate blood and tissue samples to identify predictive markers linked to these complications. The study involves regular assessments and follow-ups to gather detailed information on post-surgical outcomes and immune changes over time.
CONDITIONS
Brief Title
METabolomic and Immune PROfiling in the Development of Pancreatic Fistulas After cepHalic duodEnopancreatectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
You will not qualify if you...
- Emergent surgery
- Pregnant patients
- Refusal to participate or inability to provide informed consent
- Patient under legal protection (individuals under guardianship by court order)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospitalization period following surgery (up to 3 months)
Participants undergo pancreaticoduodenectomy surgery and are monitored immediately after the procedure.
Visits during hospitalization as part of routine care
Duration - Up to 3 months after surgery
Participants are monitored for the occurrence of clinically significant pancreatic fistulas and other post-operative complications.
Follow-up visits during the 3 months post-surgery
Trial Site Locations
Total: 1 location
1
University Hospital of Besançon
Besançon, France, 25000
Actively Recruiting
Research Team
A
Alexandre DOUSSOT, MD, PhD
A
astrid POZET
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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