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Immunoparalysis After Pancreaticoduodenectomy


2025-09-01


2026-09-01


2026-12-01


100

Study Overview

Immunoparalysis After Pancreaticoduodenectomy

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

N/A

  • Pancreatic Ductal Adenocarcinoma (mPDAC)
  • Pancreatic Head Tumour
  • Pancreatic Fistula
  • DIAGNOSTIC_TEST: mHLA-DR analysis
  • 69HCL24_1056

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2025-08-20  

N/A  

2025-08-20  

2025-08-20  

N/A  

2025-08-28  

2025-08-28  

N/A  

2025-08  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A


Allocation:
N/A


Interventional Model:
N/A


Masking:
N/A


Arms and Interventions

Participant Group/ArmIntervention/Treatment
: Adults patients undergoing Pancreaticoduodenectomy in one for a benign or malignant tumor of the pan

Biological : blood sample mHLA-DR analysis will be realized on Cyto-Chex® BCT anticoagulant tubes (5mL). Each sample will be transported and centralized at the Immunology Laboratory of Edouard Herriot Hospital and analyzed by flow cytometry. Results will

DIAGNOSTIC_TEST: mHLA-DR analysis

  • mHLA-DR analysis will be realized on Cyto-Chex® BCT anticoagulant tubes (5mL). Each sample will be transported and centralized at the Immunology Laboratory of Edouard Herriot Hospital and analyzed by flow cytometry. Samples will be collected : * The day
Primary Outcome MeasuresMeasure DescriptionTime Frame
mHLA-DR expressed by numbers of antibody per cells (Ab/C)Association of expression of mHLA-DR at POD1, POD 2 and POD3 and occurrence of pancreatic complications (CR-POPF, CR-PPAP, PACE criteria) PACE (PAncreatic Composite Endpoint) is a binary composite endpoint including : CR-POPF or Hemmorage or Reintervention (endoscopic, radiological, surgical)mHLA-DR will be assessed during 7 first days - The day of surgery right before intervention (Pre-Op) - The day of surgery immediately after intervention (Post-Op) - At postoperative day one (POD1) - At postoperative day two (POD2) - At postoperative day
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: OU Rithya

Phone Number: 06 09 32 60 60

Email: rithya.ou@chu-lyon.fr

Study Contact Backup

Name: Dr Xavier MULLER

Phone Number: 04 72 11 80 88

Email: xavier.muller@chu-lyon.fr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:

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

  • Exclusion Criteria:

  • 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available