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Can a blood test before pancreatic surgery predict a dangerous leak?

NCT ID NCT07827911

Diagnosis Sponsor: Institut Paoli-Calmettes Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers are studying whether immune markers in a blood sample taken before pancreatic cancer surgery can predict a serious complication called postoperative pancreatic fistula, where digestive fluids leak from the surgical connection. Adults scheduled for curative-intent pancreatic surgery give blood before the operation and again the next day, with follow-up for up to a year. The team will compare how well this immune signature predicts fistulas, readmissions, and early recurrence against current predictors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
blood sampling to measure immune markers before and after pancreatic surgery
What this could lead to
If the immune signature works, doctors could one day use a routine blood test before surgery to flag who is most likely to develop a pancreatic fistula and tailor care accordingly.
What could go wrong
This is an observational study, so it can show associations but not prove that the immune signature causes or reliably predicts fistulas. The signature may not perform well enough in practice, and results from this group of patients may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 310 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jan 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

malignant pancreatic neoplasm pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pancreatic cancer

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Institut Paoli-Calmettes

    Marseille, 13009, France

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