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NCT07827911
Predicting Pancreatic Fistula After Pancreatic Surgery Using Preoperative Immunity
Conditions: Pancreatic Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 310
Sponsor: Institut Paoli-Calmettes
Location: Institut Paoli-Calmettes Marseille
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 Criteria
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.
Source: ClinicalTrials.gov (NCT07827911). StuddyBuddy aggregates publicly available trial information.