NCT07144917: ImPaHLA

Immunoparalysis After Pancreaticoduodenectomy

Recruiting now Last updated 30 March 2026

What this trial tests

trial testing mHLA-DR analysis in Pancreatic Ductal Adenocarcinoma (mPDAC) in 100 participants. Currently enrolling.

Timeline

18 March 2026

Primary endpoint
18 March 2027

18 June 2027

Quick facts

Lead sponsor	Hospices Civils de Lyon
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	100
Start date	18 March 2026
Primary completion	18 March 2027
Estimated completion	18 June 2027
Sites	4 locations across France

Drugs / interventions tested

• mHLA-DR analysis

Conditions studied

• Pancreatic Ductal Adenocarcinoma (mPDAC) — all drugs for Pancreatic Ductal Adenocarcinoma (mPDAC) →
• Pancreatic Head Tumour — all drugs for Pancreatic Head Tumour →
• Pancreatic Fistula — all drugs for Pancreatic Fistula →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, any sex, with Pancreatic Ductal Adenocarcinoma (mPDAC) or Pancreatic Head Tumour. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.