Immune suppression after Whipple (pancreaticoduodenectomy)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults scheduled for pancreaticoduodenectomy (Whipple) at four centers in Lyon will be enrolled and have blood drawn before and after surgery to measure monocyte HLA-DR (mHLA-DR). The observational protocol records postoperative events including post-pancreatectomy acute pancreatitis (PPAP), clinically relevant postoperative pancreatic fistula (CR-POPF), sepsis, reoperation, and standard labs. No experimental treatment is given; clinical care follows standard practice while investigators correlate mHLA-DR trajectories with outcomes. Data will be used to see if early immune changes predict which patients develop major infectious or pancreatic complications.

Why it matters

Who can join: the full rules

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

Where it's running

• Xavier MULLER
  Lyon, France Recruiting
• Julie PERINEL
  Lyon, France Not yet recruiting
• Aurélien DUPRE
  Lyon, France Not yet recruiting
• Jean-Christophe LIFANTE
  Pierre-Bénite, France Not yet recruiting

Study contacts

• Study coordinator: OU Rithya
• Email: rithya.ou@chu-lyon.fr
• Phone: 06 09 32 60 60

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.