Actively Recruiting
Immunoparalysis After Pancreaticoduodenectomy: a Pilot Multicentric Prospective Study Based on mHLA-DR Expression
Led by Hospices Civils de Lyon · Updated on 2026-03-30
100
Participants Needed
4
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Pancreatic adenocarcinoma is a serious condition and may become the second leading cause of cancer-related death in France by 2030. Pancreaticoduodenectomy (PD) is the standard surgery for tumors in the pancreatic head, but postoperative complications remain common and can worsen patient outcomes. This study investigates how immune system changes after PD relate to severe pancreatic complications and examines whether a specific immune marker, mHLA-DR, can serve as an early warning sign for these complications. Participants will have blood samples taken to analyze mHLA-DR levels at several times: before surgery, immediately after surgery, and on postoperative days one through seven. These samples will be processed using flow cytometry in a specialized laboratory to measure mHLA-DR expression on immune cells. This observational study focuses on adults undergoing PD for benign or malignant tumors of the pancreatic head at four centers. During the study, researchers will closely monitor mHLA-DR expression over the first week after surgery. The main outcome is the number of mHLA-DR molecules per monocyte, measured at defined time points from pre-operation to postoperative day seven. This approach aims to improve understanding of immune responses linked to complications like pancreatic fistula and sepsis following PD. Participation includes blood sample collections and follow-up during the early postoperative period to assess immune changes and correlate them with clinical outcomes.
CONDITIONS
Brief 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...
- Younger than 18 years old
- Pregnant, postpartum, or breastfeeding women
- Surgery indication other than tumor-related, such as chronic pancreatitis
- Presence of an infectious syndrome at time of inclusion
- Preoperative immunosuppression
- Immunosuppressive diseases other than cancer, including congenital or acquired immune deficiency, functional hyposplenism or asplenia with long-term antibiotic prophylaxis, HIV with low CD4 count, aplasia with neutrophil count below 500 cells/mm³
- Immunosuppressive treatment other than chemotherapy, including biotherapy or corticosteroid therapy above specified doses, or 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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo pancreaticoduodenectomy surgery. Blood samples are collected the day of surgery before and after the intervention.
2 sample collections on the day of surgery
Duration - 7 days
Participants have blood samples collected daily to assess immune function for the first 7 days after surgery.
6 visits for blood sample collection from postoperative day 1 to day 7
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
D
Dr Xavier MULLER
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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