NCT06283160 METabolomic and Immune PROfiling in the Development of Pancreatic Fistulas After cepHalic duodEnopancreatectomy
| NCT ID | NCT06283160 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Besancon |
| Condition | Pancreatic Fistula |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2024-03-01 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Pancreatoduodenectomy is the standard surgical operation for benign or malign pancreatic lesions. Pancreatic Fistula (PF) or Postpancreatectomy Acute Pancreatitis (PPAP) are the major complications associated with that type of surgery. We need to develop preventive measures for these complications, which requires a better understanding of their physiopathology. The aim of this prospective monocentric and observational study is to identify predictive biomarkers and/or risk factors for PF or PPAP using metabolomics. The Profiling of circulating metabolites is indeed an original and promising approach for this purpose. We will also investigate the patient's immune status and its association with the occurrence of post-surgical complications. Participants will be adult patients scheduled to undergo elective pancreaticoduodenectomy. Surgery and patient's management will be as usual. During surgery, a fragment (0.1-0.2 g) of non-tumoral pancreatic tissue will be removed and frozen at -80°C for metabolomic analysis. For immunological assessment, 4 blood samples will be collected (before surgery and then 7 days, 1 and 3 months after, blood sampling).
Eligibility 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06283160 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Fistula. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06283160 currently recruiting?
Yes, NCT06283160 is actively recruiting participants. Contact the research team at adoussot@chu-besancon.fr for enrollment information.
Where is the NCT06283160 trial being conducted?
This trial is being conducted at Besançon, France.
Who is sponsoring the NCT06283160 clinical trial?
NCT06283160 is sponsored by Centre Hospitalier Universitaire de Besancon. The trial plans to enroll 80 participants.