NCT07827911Not yet recruiting
Predicting Pancreatic Fistula After Pancreatic Surgery Using Preoperative Immunity
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 310 (estimated)
- First submitted
- 14 Sept 2026
- Start date
- 4 Jan 2027
- Primary completion date
- 4 Jan 2032
- Lead sponsor
- Institut Paoli-Calmettes
- Diseases
- Pancreatic cancer
- NCT number
- NCT07827911
What you commit to
- Study type: Observational
- Planned participants: 310
- From 4 Jan 2027 to the primary completion date, 4 Jan 2032
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.