Predicting Pancreatic Fistula After Pancreatic Surgery Using Preoperative Immunity

N/ANot Yet RecruitingNCT07827911

Institut Paoli-Calmettes310 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

310

Conditions

Pancreatic Cancer

Interventions

blood samplingOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years * Written informed consent provided prior to study participation. * Patient scheduled to undergo curative-intent pancreatic surgery, with or without neoadjuvant treatment; preoperative biopsy is not required. * Affiliated with, or beneficiary of, a national health insurance scheme Non inclusion Criteria: * Patients scheduled to undergo total pancreatectomy for oncologic indications (e.g., intraductal papillary mucinous neoplasm \[IPMN\]). However, if a total pancreatectomy is decided intraoperatively because of a high risk of postoperative pancreatic fistula (POPF), preoperative study data and biological samples will remain eligible for inclusion in analyses comparing immunological signatures, in accordance with current clinical practice * Individuals in emergency situations, adults under legal protection (guardianship, curatorship, or judicial protection measures), or individuals unable to provide informed consent. * Inability to comply with study follow-up procedures for geographic, social, or psychological reasons.

Outcomes

Primary Outcomes

Performance of the Immunological Signature for Prediction of Clinically Relevant Postoperative Pancreatic Fistula (POPF)

Time frame: 90 days after pancreatic surgery

Secondary Outcomes

90-day Mortality

Time frame: 90 days

Change in PreCyte Score Between Preoperative and Postoperative Assessments

Time frame: From preoperative assessment (within 21 days before surgery) to postoperative day 1

Predictive Performance of the Immune Signature for 90-Day Readmission and Mortality

Time frame: 90days after surgery

One-Year Recurrence-Free Survival and Correlation With Immune Signature

Time frame: 1 year after surgery

Comparison of Postoperative PreCyte Score, Drain Fluid Amylase, and C-Reactive Protein for Outcome Prediction

Time frame: Postoperative period up to 90 days after surgery.