Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07827911). StuddyBuddy aggregates publicly available trial information.