Actively Recruiting
Immunoparalysis After Pancreaticoduodenectomy
Led by Hospices Civils de Lyon · Updated on 2026-03-30
100
Participants Needed
4
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 adenocarcinoma of the pancreatic head. Despite advances in perioperative care, morbidity remains high, and the occurrence of postoperative complications can negatively impact patient's oncologic prognosis. Sepsis is the leading cause of postoperative death following PD and it remains mainly associated with the development of a clinically-relevant postoperative pancreatic fistula (CR-POPF). More recently, post-pancreatectomy acute pancreatitis (PPAP) has been defined as a very early complication after pancreatic resection. PPAP is an ischemic and inflammatory condition of the pancreatic remnant that may be responsible for nearly half of CR-POPFs. CR-PPAP can lead to sepsis with multiorgan failure and necrotizing pancreatitis, which are with CR-POPF the two main indications for reoperation and completion pancreatectomy. Despite the major impact of severe pancreatic complications on mortality after PD, no reliable early biomarker currently exists to predict their occurence. Immunoparalysis refers to the functional impairment of immune cells with monocytes showing altered capacity of cell presentation. In classical models of inflammation such as acute pancreatitis, sepsis and surgery, the initial systemic inflammatory response syndrome is simultaneously accompanied by a compensatory anti-inflammatory reaction, which may lead to immunoparalysis. mHLA-DR (Human Leukocyte Antigen-DR on Monocytes) is considered as the most appropriate biomarker to assess this immune dysfonction. Various studies emphasize the predictive value of mHLA-DR for early detection of adverse outcomes : in acute pancreatitis, mHLA-DR predicts the onset of severe forms as early as admission and after colorectal surgery, mHLA-DR enables earlier detection of anastomotic leakage compared to conventional biomarkers. The main hypothesis is that the severity of postoperative complications is driven by immunological factors. On one hand, this study seeks to improve the understanding of the relationship between the immune response after PD and the occurrence of pancreatic complications. On the other hand, it aims to assess if mHLA-DR could represent an early biomarker for detecting severe pancreatic complications. Therefore, the main objective of this study is to evaluate the association of mHLA-DR expression in the early postoperative period following PD and the occurrence of severe pancreatic complications
CONDITIONS
Official Title
Immunoparalysis After Pancreaticoduodenectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any patient undergoing a Pancreaticoduodenectomy in one of the four participating centers for a benign or malignant tumor of the pancreatic head
You will not qualify if you...
- Age under 18 years
- Pregnant, postpartum, or breastfeeding women
- Surgery indication other than tumor-related, such as chronic pancreatitis
- Presence of an infectious syndrome at the time of inclusion
- Preoperative immunosuppression
- Immunosuppressive diseases other than cancer including congenital or acquired immune deficiency
- Functional hyposplenism or asplenia or patient under long-term antibiotic prophylaxis for this reason
- HIV infection with low CD4 cell count
- Aplasia defined by circulating neutrophil count under 500 cells/mm³
- Immunosuppressive treatment other than chemotherapy, including biotherapy or corticosteroid therapy above specified doses
- Expected immunosuppressive treatment within the first 7 postoperative days
- Individuals deprived of liberty by judicial or administrative decision
- Adults under legal protection such as guardianship or curatorship
- Individuals not covered by social security or equivalent
- Refusal to participate in the study
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Julie PERINEL
Lyon, France, 69003
Not Yet Recruiting
2
Xavier MULLER
Lyon, France, 69004
Actively Recruiting
3
Aurélien DUPRE
Lyon, France, 69008
Not Yet Recruiting
4
Jean-Christophe LIFANTE
Pierre-Bénite, France, 69495
Not Yet Recruiting
Research Team
O
OU Rithya
CONTACT
D
Dr Xavier MULLER
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
1
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