Health TrialsbyHealthPanel

Predicting Pancreatic Fistula After Pancreatic Surgery Using Preoperative Immunity

ConditionPancreatic Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut Paoli-Calmettes

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • blood sampling

    Other intervention

    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.

Treatment groups

310 Participants
are divided into 1 treatment group
Group A: Patients undergoing pancreatic surgery1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut Paoli-Calmettes

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: