Actively Recruiting

Age: 18Years +
All Genders
NCT07144917

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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Immunoparalysis After Pancreaticoduodenectomy | DecenTrialz