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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06283160
Other study ID # 2023/834
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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