Predicting Pancreatic Fistula After Pancreatic Surgery Using Preoperative Immunity

NCT07827911 | Not Yet Recruiting

• 1 other identifier: IMMUNOPANC-2-IPC 2024-036
• Study Type: observational
• Target: 310
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

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

  90 days after pancreatic surgery

Secondary Outcomes (5)

• 90-day Mortality

  90 days

• Change in PreCyte Score Between Preoperative and Postoperative Assessments

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

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

  90days after surgery

• One-Year Recurrence-Free Survival and Correlation With Immune Signature

  1 year after surgery

• Comparison of Postoperative PreCyte Score, Drain Fluid Amylase, and C-Reactive Protein for Outcome Prediction

  Postoperative period up to 90 days after surgery.

Study Arms (1)

Patients undergoing pancreatic surgery

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).

Other: blood sampling

Interventions

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.

Patients undergoing pancreatic surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult (≥18 years) undergoing elective curative-intent pancreatic surgery (pancreaticoduodenectomy or distal pancreatectomy) for benign or malignant pancreatic tumors, with or without neoadjuvant therapy.

You may qualify if:

• 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
• 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.

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Institut Paoli-Calmettes

Marseille, 13009, France

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Jihane PAKRADOUNI, PhD

CONTACT

+33491223778; drci.up@ipc.unicancer.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start (Estimated): January 4, 2027
• Primary Completion (Estimated): January 4, 2032
• Study Completion (Estimated): January 4, 2032
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)