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

NCT06283160 | Recruiting

• 1 other identifier: 2023/834
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Pancreatic Fistula; Acute Pancreatitis; Pancreatoduodenectomy

Keywords

Metabolomics; Immune response; Pancreatic fistula; pancreatoduodenectomy

Outcome Measures

Primary Outcomes (1)

• occurrence of clinically significant FP and/or PAPP during hospitalization following pancreaticoduodenectomy.

  3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be made of adult patients scheduled to undergo elective pancreaticoduodenectomy in the University hospital of Besançon (France)

You may qualify if:

• 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 may not qualify if:

• Emergent surgery.
• Pregnant patients.
• Refusal to participate or inability to provide informed consent.
• Patient under legal protection (individuals under guardianship by court order).

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

University Hospital of Besançon

Besançon, 25000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Non tumoral pancreas (\<0.2g) Blood samples

MeSH Terms

Conditions

Pancreatic Fistula; Pancreatitis

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alexandre DOUSSOT, MD, PhD

CONTACT

+33381668343; adoussot@chu-besancon.fr

astrid POZET

CONTACT

+33381218988; apozet@chu-besancon.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 28, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-09

Locations

FR (1)