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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2026-05-30

Brief Summary

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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).

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Tumors

COMPLETED PHASE3

Detailed Description

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Conditions

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Pancreatic Fistula Acute Pancreatitis Pancreatoduodenectomy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No