Immune suppression after Whipple (pancreaticoduodenectomy)
Immunoparalysis After Pancreaticoduodenectomy : a Pilot Multicentric Prospective Study Based on mHLA-DR Expression
Hospices Civils de Lyon · NCT07144917
This will test whether measuring patients' immune function (mHLA-DR) after a Whipple operation for a pancreatic head tumor can identify people at higher risk of serious infections or pancreatic complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon (other) |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Lyon and 3 other locations) |
| Trial ID | NCT07144917 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults undergoing a Whipple operation for a benign or malignant tumor of the pancreatic head at one of the participating Lyon centers who are not pregnant and do not have active infection or major preoperative immunosuppression are ideal candidates.
Not a fit: Patients with preexisting immunosuppression, active infection at inclusion, non–tumor surgical indications (e.g., chronic pancreatitis), minors, pregnant or breastfeeding women, or those treated outside the participating centers are unlikely to benefit from this observational protocol.
Why it matters
Potential benefit: If successful, perioperative mHLA-DR measurement could help doctors identify patients at high risk of sepsis or pancreatic complications so they can increase monitoring or tailor interventions to reduce harm.
How similar studies have performed: mHLA-DR has been used as a marker of immunoparalysis in sepsis and after major surgery with prior studies showing associations with infection risk, but its specific predictive role after pancreaticoduodenectomy remains incompletely established.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lyon and 3 other locations
- Julie PERINEL — Lyon, France (NOT_YET_RECRUITING)
- Xavier MULLER — Lyon, France (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pancreatic Ductal Adenocarcinoma, Pancreatic Head Tumour, Pancreatic Fistula, Pancreaticoduocenectomy, Pancreatic fistula, Post-Operative Pancreatic Fistula, Post-Pancreatectomy Acute Pancreatitis, Pancreatic complications