Acute Necrotizing PancreatitisPancReaNCT03253861
PancRea: Risk Factors and Outcomes of Infected Pancreatic Necrosis
An observational study of Acute Necrotizing Pancreatitis and Infection, run by Nantes University Hospital at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Necrotizing Pancreatitis, Infection, Pancreatitis
- How many people
- 148 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2016to 1 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- mild acute pancreatitis, defined as no organ failure or local complication (No necrosis or peri-pancreatic collection)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Acute Necrotizing Pancreatitis, Infection, Pancreatitis
- Being tested
- No intervention
- 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
- Medical subject headings
- Pancreatitis, Acute Necrotizing, Infections, Pancreatitis, Sepsis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| control patients | patients without an infected pancreatic necrosis Receives: Other: No intervention | |
| Case patients | patients with an infected pancreatic necrosis Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start1 Jun 2016
- Primary completion1 Jan 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Necrotizing PancreatitisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlotte Garret, MD, Principal investigator, Nantes CHU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253861
- Sponsor's protocol ID
- RC16_0126
- Acronym
- PancRea
- Status last verified
- Aug 2017
- First submitted
- 16 Aug 2017
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Outcomes of Infected Pancreatic Necrosis: Retrospective Cohort of 148 Patients Admitted to the ICU for Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT03253861
- Acronym / sponsor ID
- PancRea / RC16_0126
- Conditions
- Acute Necrotizing Pancreatitis, Infection, Pancreatitis
- Keywords
- Acute necrotizing pancreatitis, Acute pancreatitis, Sepsis/complications, Infection, Organ Dysfunction Scores, Drainage, Catheters, Antibiotics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 18 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control patients | – | Other: No interventionpatients without an infected pancreatic necrosis |
| Case patients | – | Other: No interventionpatients with an infected pancreatic necrosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- mild acute pancreatitis, defined as no organ failure or local complication (No necrosis or peri-pancreatic collection)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Case patients, control patients |
Primary outcome
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
1 secondary outcome
Risk factors of mortality
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Derived from this study: PubMed 32542577Garret 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte Garret, MD principal investigator
Nantes CHU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Necrotizing Pancreatitis and Infection, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factors of infected pancreatic necrosis (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03253861, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.