Pancreatic Ductal Adenocarcinoma (mPDAC)ImPaHLANCT07144917
Immunoparalysis After Pancreaticoduodenectomy
An observational study of Pancreatic Ductal Adenocarcinoma (mPDAC) and Pancreatic Head Tumour, run by Hospices Civils de Lyon at 4 sites in France.
Trial 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 adenocarcinoma of the pancreatic head. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (mPDAC), Pancreatic Head Tumour, Pancreatic Fistula
- What is being tested?
- mHLA-DR analysis
- How many people
- 100 participants
- Where
- 4 sitesFrance
- Study dates
- 18 Mar 2026to 18 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 patients undergoing a Pancreaticoduodenectomy in one of the four participating centers for a benign or malignant tumor of the pancreatic head will be included. Participating centers : Hospices Civils de Lyon (Edouard Herriot Hospital, Croix-Rousse Hospital, Lyon Sud Hospital) and Centre Léon Bérard, Lyon, France
Who may be able to join
- Any patient undergoing a Pancreaticoduodenectomy in one of the four participating centers for a benign or malignant tumor of the pancreatic head
Who cannot join
- 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:
Show all 15Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Not yet recruiting
Julie PERINEL
Lyon, 69003
Julie PERINEL, PHU, 0472116261, julie.perinel@chu-lyon.fr
- Recruiting
Xavier MULLER
Lyon, 69004
Xavier MULLER, Dr, 0472118088, xavier.muller@chu-lyon.fr
- Not yet recruiting
Aurélien DUPRE
Lyon, 69008
Aurélien DUPRE, PU-PH, 0478782828, aurelien.dupre@lyon.unicancer.fr
- Not yet recruiting
Jean-Christophe LIFANTE
Pierre-Bénite, 69495
Jean-Christophe LIFANTE, PU-PH, 0478569095, jean-christophe.lifante@chu-lyon.fr
About this study
Official title: Immunoparalysis After Pancreaticoduodenectomy : a Pilot Multicentric Prospective Study Based on mHLA-DR Expression
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.
Read more
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
- Being tested
- mHLA-DR analysis
- Keywords
- Pancreaticoduocenectomy, Pancreatic fistula, Post-Operative Pancreatic Fistula, Post-Pancreatectomy Acute Pancreatitis, Pancreatic complications, Sepsis, mHLA-DR, Immunparalysis, Immunosuppression
- Medical subject headings
- Pancreatic Fistula, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHLA-DR analysisDiagnostic test
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 of surgery before intervention
- The day of surgery after intervention
- At postoperative day one
- At postoperative day two
- At postoperative day three
- At postoperative day four
- At postoperative day five
- At postoperative day seven
| Study group | Role | What they receive |
|---|---|---|
| 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 be expressed as number of receptors per monocyte (Ab/C)
Samples will be collected :
* The day of surgery before intervention
* The day of surgery after intervention
* At postoperative day one
* At postoperative day two
* At postoperative day three
* At postoperative day four
* At postoperative day five
* At postoperative day seven Receives: Diagnostic Test: mHLA-DR analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start18 Mar 2026
- Primary completion18 Mar 2027 (estimated)
- Study completion18 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal Adenocarcinoma (mPDAC)Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144917
- Sponsor's protocol ID
- 69HCL24_1056
- Acronym
- ImPaHLA
- Status last verified
- Mar 2026
- First submitted
- 20 Aug 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunoparalysis After Pancreaticoduodenectomy : a Pilot Multicentric Prospective Study Based on mHLA-DR Expression
- ClinicalTrials.gov ID
- NCT07144917
- Acronym / sponsor ID
- ImPaHLA / 69HCL24_1056
- Keywords
- Pancreaticoduocenectomy, Pancreatic fistula, Post-Operative Pancreatic Fistula, Post-Pancreatectomy Acute Pancreatitis, Pancreatic complications, Sepsis, mHLA-DR, Immunparalysis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 18 Mar 2027 (estimated)
- Study completion
- 18 Jun 2027 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults patients undergoing Pancreaticoduodenectomy in one for a benign or malignant tumor of the pan | – | Diagnostic Test: mHLA-DR analysisBiological : 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 be expressed as number of receptors per monocyte (Ab/C) Samples will be collected : * The day of surgery before intervention * The day of surgery after intervention * At postoperative day one * At postoperative day two * At postoperative day three * At postoperative day four * At postoperative day five * At postoperative day seven |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 patients undergoing a Pancreaticoduodenectomy in one of the four participating centers for a benign or malignant tumor of the pancreatic head will be included. Participating centers : Hospices Civils de Lyon (Edouard Herriot Hospital, Croix-Rousse Hospital, Lyon Sud Hospital) and Centre Léon Bérard, Lyon, France
Key inclusion criteria (1 listed)
- Any patient undergoing a Pancreaticoduodenectomy in one of the four participating centers for a benign or malignant tumor of the pancreatic head
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHLA-DR analysismHLA-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 of surgery before intervention * The day of surgery after intervention * At postoperative day one * At postoperative day two * At postoperative day three * At postoperative day four * At postoperative day five * At postoperative day seven | Diagnostic test | Adults patients undergoing Pancreaticoduodenectomy in one for a benign or malignant tumor of the pan |
Primary outcome
mHLA-DR expressed by numbers of antibody per cells (Ab/C)
Time frame: 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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Ductal Adenocarcinoma (mPDAC) and Pancreatic Head Tumour, run by Hospices Civils de Lyon at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact OU Rithya (06 09 32 60 60, rithya.ou@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mHLA-DR expressed by numbers of antibody per cells (Ab/C) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.