Actively Recruiting

Age: 18Years +
All Genders
NCT06283160

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

Led by Centre Hospitalier Universitaire de Besancon · Updated on 2024-10-15

80

Participants Needed

1

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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)
Not Eligible

You will not qualify if you...

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

AI-Screening

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Trial Site Locations

Total: 1 location

1

University Hospital of Besançon

Besançon, France, 25000

Actively Recruiting

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Research Team

A

Alexandre DOUSSOT, MD, PhD

CONTACT

A

astrid POZET

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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