ClinicalTrials.gg
Not yet recruitingNCT07827911Updated Sep 18, 2026

Predicting Pancreatic Fistula After Pancreatic Surgery Using Preoperative Immunity

An observational study in Pancreatic Cancer, sponsored by Institut Paoli-Calmettes. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by Institut Paoli-Calmettes · Observational

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Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
310
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 19 studies in Pancreatic Neoplasms by Institut Paoli-Calmettes — 7 open to participants now, 8 under way, none of them phase 3. Pancreatic Neoplasms · Institut Paoli-Calmettes.

Started
2027
the only one that year
Observational
7 of 19
3 open now
Registered
19th of 19
by date

Among the 19 studies in Pancreatic Neoplasms by Institut Paoli-Calmettes, this one is the only one that started in 2027, is one of 7 observational ones, and was the 19th registered.

Pancreatic Neoplasms

3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,005 are open to participants now.

Browse Pancreatic Neoplasms studies →

Open to participants now

7 of the 19 studies in Pancreatic Neoplasms by Institut Paoli-Calmettes are open now, in 1 country. Recruiting first, the newest first:

1 more — sign in →

By country, each count listing its studies:

All 7 open studies →

Where they have run

Who these studies take

Of the 745 Pancreatic Neoplasms studies recruiting now, 478 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.
03

Conditions studied

  • Pancreatic Cancer
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Eligibility criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Written provided prior to study participation.
  • Patient scheduled to undergo curative-intent pancreatic surgery, with or without treatment; preoperative 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
310 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Otherblood sampling

    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.

06

What researchers measure

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.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2027; primary completion for Jan 2032, 60 months later.

Of 318 non-industry observational studies under Pancreatic Neoplasms, half reached primary completion within 74 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 182. This study's planned 60 months is below that.

Counting every sponsor, half of 352 studies reached it within 60 months; a quarter within 34 and three quarters within 182.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2026
First posted
Sep 18, 2026
StartEst.
Jan 4, 2027
Primary completionEst.
Jan 4, 2032
CompletionEst.
Jan 4, 2032
Last update
Sep 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07827911
Responsible party
Sponsor
First posted
Sep 18, 2026
Start date
Jan 4, 2027 (estimated)
Primary completion
Jan 4, 2032 (estimated)
Completion
Jan 4, 2032 (estimated)
Last update
Sep 18, 2026

Study contacts

Jihane PAKRADOUNI, PhD
Contact
drci.up@ipc.unicancer.fr
+33491223778

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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