METabolomic and Immune PROfiling in the Development of Pancreatic Fistulas After cepHalic duodEnopancreatectomy

Interest of Metabolomic and Immune Profiling in the Development of Pancreatic Fistulas After Duodenopancreatectomy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06283160

Acronym

PROMETHEE

Enrollment

Registered

2024-02-28

Start date

2024-03-01

Completion date

2026-05-30

Last updated

2024-10-15

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

Conditions

Acute Pancreatitis, Pancreatic Fistula, Pancreatoduodenectomy

Keywords

Metabolomics, Immune response, Pancreatic fistula, pancreatoduodenectomy

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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame
occurrence of clinically significant FP and/or PAPP during hospitalization following pancreaticoduodenectomy.	3 months

Countries

France

Contacts

Primary ContactAlexandre DOUSSOT, MD, PhD

adoussot@chu-besancon.fr+33381668343

Backup Contactastrid POZET

apozet@chu-besancon.fr+33381218988

Outcome results