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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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. 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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

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

Locations
Other Locations
France
Aurélien DUPRE
NOT_YET_RECRUITING
Lyon
Julie PERINEL
NOT_YET_RECRUITING
Lyon
Xavier MULLER
RECRUITING
Lyon
Jean-Christophe LIFANTE
NOT_YET_RECRUITING
Pierre-bénite
Contact Information
Primary
OU Rithya
rithya.ou@chu-lyon.fr
06 09 32 60 60
Backup
Dr Xavier MULLER
xavier.muller@chu-lyon.fr
04 72 11 80 88
Time Frame
Start Date: 2026-03-18
Estimated Completion Date: 2027-06-18
Participants
Target number of participants: 100
Treatments
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
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov