- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03253861
PancRea: Risk Factors and Outcomes of Infected Pancreatic Necrosis (PancRea)
June 23, 2026 updated by: Nantes University Hospital
Risk Factors and Outcomes of Infected Pancreatic Necrosis: Retrospective Cohort of 148 Patients Admitted to the ICU for Acute Pancreatitis
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
148
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Nantes, France, 44093
- CHU de Nantes
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
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
Description
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:
- mild acute pancreatitis, defined as no organ failure or local complication (No necrosis or peri-pancreatic collection)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
control patients
patients without an infected pancreatic necrosis
|
No intervention
|
|
Case patients
patients with an infected pancreatic necrosis
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Risk factors of infected pancreatic necrosis
Time Frame: 4 months
|
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
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Risk factors of mortality
Time Frame: 4 months
|
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
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Charlotte Garret, MD, Nantes CHU
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2016
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
August 16, 2017
First Submitted That Met QC Criteria
August 16, 2017
First Posted (Actual)
August 18, 2017
Study Record Updates
Last Update Posted (Actual)
June 24, 2026
Last Update Submitted That Met QC Criteria
June 23, 2026
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
- Infection
- Antibiotics
- Drainage
- Catheters
- Acute pancreatitis
- Acute necrotizing pancreatitis
- Sepsis/complications
- Organ Dysfunction Scores
- Multiresistant organism
- Pancreatitis/complications
- Pancreatitis/diagnosis
- Pancreatitis/surgery
- Pancreatitis/therapy
- Pancreatitis, Acute Necrotizing/complications
- Pancreatitis, Acute Necrotizing/surgery
- Pancreatitis, Acute Necrotizing/therapy
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC16_0126
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.