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NCT07144917Recruiting

Immunoparalysis After Pancreaticoduodenectomy

Immunoparalysis After Pancreaticoduodenectomy : a Pilot Multicentric Prospective Study Based on mHLA-DR Expression

Source: ClinicalTrials.gov · Last updated 30 Mar 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Observational
Enrollment
100 (estimated)
First submitted
20 Aug 2025
Start date
18 Mar 2026
Primary completion date
18 Mar 2027
Lead sponsor
Hospices Civils de Lyon
NCT number
NCT07144917

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From 18 Mar 2026 to the primary completion date, 18 Mar 2027
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patient with an infectious syndrome at the time of inclusion

Lab values

  • 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

Age

  • Age \< 18 years

Other

  • Pregnant, postpartum, or breastfeeding women
  • Indication other than tumor-related (e.g., chronic pancreatitis)
  • Preoperative immunosuppression
  • 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

Who the study is looking for

  • Any patient undergoing a Pancreaticoduodenectomy in one of the four participating centers for a benign or malignant tumor of the pancreatic head

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Aurélien DUPRE
Coordinator of this site? Confirm its status
LyonFranceNot yet recruiting
Xavier MULLER
Coordinator of this site? Confirm its status
LyonFranceRecruiting
Julie PERINEL
Coordinator of this site? Confirm its status
LyonFranceNot yet recruiting
Jean-Christophe LIFANTE
Coordinator of this site? Confirm its status
Pierre-BéniteFranceNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.