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

Acute Pancreatitis Clinical Trial

— PROMETHEE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06283160
• Other study ID #: 2023/834
• Status: Recruiting
• Start date: March 1, 2024
• Est. completion date: May 30, 2026

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Alexandre DOUSSOT, MD, PhD
• Phone: +333812189888
• Email: adoussot[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pancreaticoduodenectomy 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 30, 2026
• Est. primary completion date: May 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Acute Pancreatitis
• Fistula
• Pancreatic Fistula
• Pancreatitis

Locations

Country	Name	City	State
France	University Hospital of Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of clinically significant FP and/or PAPP during hospitalization following pancreaticoduodenectomy.		3 months