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NCT Number: NCT07827911

Predicting Pancreatic Fistula After Pancreatic Surgery Using Preoperative Immunity

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sampling

Other

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.

Primary outcomes

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

    Time frame: 90 days after pancreatic surgery

Secondary outcomes

  1. 90-day Mortality

    Time frame: 90 days

  2. Change in PreCyte Score Between Preoperative and Postoperative Assessments

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

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

    Time frame: 90days after surgery

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

    Time frame: 1 year after surgery

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jihane PAKRADOUNI, PhD

CONTACT

[email protected]

+33491223778

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Important dates

Study start
2027
Primary completion
2032
Study completion
2032
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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