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

Recruiting

• Conditions: Pancreatic Fistula; Acute Pancreatitis; Pancreatoduodenectomy

• Registration Number: NCT06283160
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-22
• Study First Submitted QC: 2024-02-22
• Study First Posted: 2024-02-28
• Study Start: 2024-03-01
• Status Verified: 2024-09
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-14
• Primary Completion: 2026-05-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital of Besançon; 🇫🇷 Besançon, France