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CompletedNCT03253861PancReaUpdated Jun 24, 2026

PancRea: Risk Factors and Outcomes of Infected Pancreatic Necrosis

An observational study in Acute Necrotizing Pancreatitis, Infection and Pancreatitis, sponsored by Nantes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by Nantes University Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
148
Ages
18 Years and older
Sex
All
01

Study summary

Severe acute pancreatitis is a common reason for intensive care unit (ICU) admission and is associated with prolonged hospital stays and high morbidity and mortality rates. The Atlanta classification differentiates mild, moderate, and severe acute pancreatitis, and each of these categories correlates with morbidity and mortality. Mortality remains high, between 10% and 39%, in severe and moderately severe acute pancreatitis. After the first week, about 30% of patients with necrotizing pancreatitis develop infected pancreatic necrosis (IPN). IPN is a risk factor for mortality.The treatment of IPN combines antibiotics with interventions to remove the infected intra-abdominal material, preferably using minimally invasive techniques such as percutaneous and endoscopic drainage, which have been proven beneficial. In several studies biological markers such as procalcitonin and interleukin 8 were effective in predicting IPN. However, few clinical risk factors for IPN have been reported. Identifying risk factors may help to improve standardized strategies for early diagnosis and treatment, and then patients outcome. Our primary objective was to identify risk factors for IPN in patients admitted to the ICU for acute pancreatitis. Our secondary objective was to describe the management and outcomes of IPN

Read the detailed description

Using electronic patient data monitoring systems, the investigators reviewed all patients with a diagnosis of acute necrotizing pancreatitis admitted to digestive liver disease unity or ICUs at the Nantes University Hospital, from January 1, 2012, to december 31, 2015. For enrolled patients, general clinical characteristics were collected. Patients were categorized into two groups according to the development of an infected pancreatic necrosis (highly suspected or proven), and the differences of these characteristics between two groups were evaluated. Potential risk factors were collected and studied by using multiple logistic regression analysis.

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Conditions studied

  • Acute Necrotizing Pancreatitis
  • Infection
  • Pancreatitis

Keywords

  • Acute necrotizing pancreatitis
  • Acute pancreatitis
  • Sepsis/complications
  • Infection
  • Organ Dysfunction Scores
  • Drainage
  • Catheters
  • Antibiotics
  • Multiresistant organism
  • Pancreatitis/complications
  • Pancreatitis/diagnosis
  • Pancreatitis/surgery
  • Pancreatitis/therapy
  • Pancreatitis, Acute Necrotizing/complications
  • Pancreatitis, Acute Necrotizing/surgery
  • Pancreatitis, Acute Necrotizing/therapy
03

In context

Pancreatitis, Acute Necrotizing

74 studies on the registry are indexed under Pancreatitis, Acute Necrotizing; 19 are open to participants now.

This study's enrollment of 148 is above the median of 100 across 25 observational studies indexed under Pancreatitis, Acute Necrotizing.

Browse Pancreatitis, Acute Necrotizing studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with acute necrotizing pancreatitis admitted in an ICU between January 2012 and December 2015 for moderately severe or severe acute pancreatitis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients (age >18 years) with acute necrotizing pancreatitis admitted in an ICU between January 2012 and December 2015 for moderately severe or severe acute pancreatitis were included.
  • Organ failure that resolves within 48 h (transient organ failure) and/or local or systemic complications without persistent organ failure or persistent organ failure (>48 h)

Exclusion criteria

Exclusion Criteria:

  • mild acute pancreatitis, defined as no organ failure or local complication (No necrosis or peri-pancreatic collection)
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
148 participants (actual)
Patient registry
No

Groups and cohorts

  • control patients

    patients without an infected pancreatic necrosis

    Other: No intervention

  • Case patients

    patients with an infected pancreatic necrosis

    Other: No intervention

Interventions

  • OtherNo intervention

    No intervention

06

What researchers measure

Primary outcomes

  1. Risk factors of infected pancreatic necrosis

    Potential risk factors included patient demographics, disease severity, complications, morphology on CT, and details of the drainage procedure. Univariate analyses examined potential risk factors on outcome (catheter drainage failure). Then, using multiple logistic regression analysis, factors achieving P≤0.1 in univariate analyses were entered into the model predicting the risk of catheter drainage failure

    Time frame: 4 months

Secondary outcomes

  1. Risk factors of mortality

    Potential risk factors included patient demographics, disease severity, complications, morphology on CT, and details of the drainage procedure. Univariate analyses examined potential risk factors on outcome (mortality). Then, using multiple logistic regression analysis, factors achieving P≤0.1 in univariate analyses were entered into the model predicting the risk of non-survival

    Time frame: 4 months

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Study locations

1 site
  • CHU de Nantes
    Nantes, 44093, France
08

References and documents

Publications

  • Garret C, Canet E, Corvec S, Boutoille D, Peron M, Archambeaud I, Le Thuaut A, Lascarrou JB, Douane F, Lerhun M, Regenet N, Coron E, Reignier J. Impact of prior antibiotics on infected pancreatic necrosis microbiology in ICU patients: a retrospective cohort study. Ann Intensive Care. 2020 Jun 15;10(1):82. doi: 10.1186/s13613-020-00698-0. PubMed 32542577 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2016 to primary completion in Jan 2017, 7 months.

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

Registered
Aug 16, 2017
First posted
Aug 18, 2017
StartActual
Jun 1, 2016
Primary completionActual
Jan 1, 2017
CompletionActual
Jun 1, 2017
Last update
Jun 24, 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 Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03253861
Responsible party
Sponsor
First posted
Aug 18, 2017
Start date
Jun 1, 2016
Primary completion
Jan 1, 2017
Completion
Jun 1, 2017
Last update
Jun 24, 2026

Study contacts

Charlotte Garret, MD
principal investigator · Nantes CHU

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 completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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