Predicting Pancreatic Fistula After Pancreatic Surgery Using Preoperative Immunity

Condition(s) studied

Investigational drug(s) / intervention(s)

blood sampling: Peripheral blood samples will be collected preoperatively (within 21 days before planned pancreatic surgery) and on postoperative day 1. Clinical data will be collected at the same time points and during routine follow-up at 3, 6, and 12 months. Blood samples will be used to characterize an immunological signature and perioperative immune response in patients undergoing pancreatic surgery.

Study summary

The goal of this observational study is to develop and validate a preoperative immunological signature for predicting postoperative pancreatic fistula (POPF) in adult patients undergoing pancreatic surgery for pancreatic cancer.

The main questions it aims to answer are:

* Can a preoperative immunological signature accurately predict the occurrence of postoperative pancreatic fistula after pancreatic surgery?
* Does the immunological signature provide better predictive performance than currently available predictors? Researchers will also evaluate whether the immunological signature is associated with postoperative readmission, 90-day mortality, and early disease recurrence within one year after surgery.

Participants will:

* Provide a blood sample during the preoperative assessment visit.
* Provide a second blood sample on the day following pancreatic surgery.
* Undergo standard postoperative and oncological follow-up for up to 12 months. This is a prospective, multi-center, open-label observational study conducted at Institut Paoli-Calmettes. A total of 310 participants will be enrolled.

Eligibility

Primary outcome measure(s)

• Performance of the Immunological Signature for Prediction of Clinically Relevant Postoperative Pancreatic Fistula (POPF) — 90 days after pancreatic surgery

Trial sites (1)

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