Status:
NOT_YET_RECRUITING
Immunoparalysis After Pancreaticoduodenectomy
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Pancreatic Ductal Adenocarcinoma (mPDAC)
Pancreatic Head Tumour
Eligibility:
All Genders
18+ years
Brief Summary
By 2030, pancreatic adenocarcinoma could become the second leading cause of cancer-related death in France. To date, Pancreaticoduodenectomy (PD) is the standard treatment for resectable adenocarcinom...
Eligibility Criteria
Inclusion
- Any patient undergoing a Pancreaticoduodenectomy in one of the four participating centers for a benign or malignant tumor of the pancreatic head
Exclusion
- Age \< 18 years
- Pregnant, postpartum, or breastfeeding women
- Indication other than tumor-related (e.g., chronic pancreatitis)
- Patient with an infectious syndrome at the time of inclusion
- Preoperative immunosuppression
- Immunosuppressive disease other than cancer:
- Congenital or acquired immune deficiency
- Functional hyposplenism or asplenia, patient under long-term antibiotic prophylaxis for this reason
- Patient with HIV (and CD4 \< cells/mm³)
- Aplasia defined by circulating neutrophil count \< 500 cells/mm³
- Immunosuppressive treatment other than chemotherapy : Biotherapy, Corticosteroid therapy \>10 mg/day or cumulative dose \>700 mg prednisolone equivalent : Patient expected to receive immunosuppressive treatment within the first 7 postoperative days
- Individuals deprived of liberty by judicial or administrative decisio
- Adults under legal protection (guardianship or curatorship)
- Individuals not affiliated with a social security scheme or an equivalent coverage
- Refusal to participate in the study
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07144917
Start Date
September 1 2025
End Date
December 1 2026
Last Update
August 28 2025
Active Locations (4)
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1
Julie PERINEL
Lyon, France, 69003
2
Xavier MULLER
Lyon, France, 69004
3
Aurélien DUPRE
Lyon, France, 69008
4
Jean-Christophe LIFANTE
Pierre-Bénite, France, 69495