Clinical trial · Observational
Predicting Pancreatic Fistula After Pancreatic Surgery Using Preoperative Immunity
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood sampling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients undergoing pancreatic surgery
- description
- Adult (≥18 years) undergoing elective pancreatic surgery, for a benign or malignant pancreatic tumor. Participants will provide blood samples before surgery and on the first postoperative day for immunological and proteomic analyses aimed at developing and validating a predictive signature of postoperative pancreatic fistula (POPF).
- interventionNames
- Other: blood sampling
Primary outcomes (1)
- measure
- Performance of the Immunological Signature for Prediction of Clinically Relevant Postoperative Pancreatic Fistula (POPF)
- timeFrame
- 90 days after pancreatic surgery
Secondary outcomes (5)
- measure
- 90-day Mortality
- timeFrame
- 90 days
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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