Acute Necrotizing PancreatitisPANICNCT03234166
Acute Necrotizing Pancreatitis and Infected Pancreatic Necrosis
An observational study of Acute Necrotizing Pancreatitis, run by Nantes University Hospital at 4 sites in France.
Trial summary
Acute necrotizing pancreatitis is a frequent and potentially lethal disease, especially in case of infected pancreatic necrosis (IPN). IPN usually occurs after the first week of evolution. The step up approach is now widely recommended for the management of IPN. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Necrotizing Pancreatitis
- What is being tested?
- Non interventional study
- How many people
- 72 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Mar 2018to 1 Mar 2019
- 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: Major patient, hospitalized with a diagnosis of acute necrotizing pancreatitis between 2012 and 2016, whatever the etiology, complicated by a necrosis infection infection (either proven or strongly suspected) requiring the initiation of antibiotic therapy and a drainage gesture of this CCM.
Who may be able to join
- Adult patients (age >18 years) with acute necrotizing pancreatitis
- IPN proven or highly suspected (proven=positive cultures on pancreatic collections or gas on CT, highly suspected= sepsis without any others infection)
- The need for a catheter drainage
- Non inclusion Criteria:
- patients under 18 years
- lack of radiologic evidence to diagnose acute necrotizing pancreatitis,
Show all 10Show fewer
- no suspicion or confirmation of IPN
- no need for a drainage
- unable to receive a drainage
- pregnancy
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Angers University Hospital
Angers, 49100
Brest University Hospital
Brest, 29200
Nantes University Hospital
Nantes, 44093
Rennes University Hospital
Rennes, 35033
About this study
Official title: Acute Necrotizing Pancreatitis and Infected Pancreatic Necrosis: Can we Predict Primary Drainage Failure?
Acute necrotizing pancreatitis is a frequent and potentially lethal disease, especially in case of infected pancreatic necrosis (IPN). IPN usually occurs after the first week of evolution. The step up approach is now widely recommended for the management of IPN. In fact, in case of suspicion of IPN, a drainage percutaneous or transgastric is recommended at first, supported by probabilist antibiotherapy. 1/3 of patients won't require any other interventions. For 2/3 of patients, an additional necrosectomy is necessary. Necrosectomy was formally realized by open laparotomy. Since de last decade, mini-invasive technics have emerged: transgastric necrosectomy, video-assist retroperitoneal debridement. laparoscopy and permitted a decreased of morbidity and mortality. Recently, Hollemans et al. developed a nomogram based on 4 variables (sex, multi-organ failure, % of necrosis and collections heterogeneity) which are negative predictors for success of catheter drainage in IPN with an receiver operating characteristic (ROC) curve at 0.76. The aim of this study is to validate on a large retrospective cohort Hollemans nomogram in predicting catheter drainage success. Secondary aims are to evaluate possible others predictors for success of catheter drainage in IPN and to evaluate the impact of antibiotherapy on microbiological results and on the need for an additional necrosectomy regarding its type and duration, as well as the emergence of multiresistance organism.
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, Rennes, Angers and Brest University Hospital from January 1, 2012, to december 31, 2017. For enrolled patients, general clinical characteristics were collected. Patients were categorized into two groups according to success of catheter drainage or failure of catheter drainage, and the differences of these characteristics between two groups were evaluated. The Hollemans nomogram is evaluate and potential risk factors will be collected and studied by using multiple logistic regression analysis.
- Conditions
- Acute Necrotizing Pancreatitis
- Being tested
- Non interventional study
- Keywords
- Acute necrotizing pancreatitis Acute pancreatitis Pancreas disease Sepsis Infection Drainage Catheters Antibiotics Multiresistant organism
- Medical subject headings
- Pancreatitis, Acute Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventional studyOther
Only data will be taken of patient's file.
What is being measured
The primary outcome is the main question the study is designed to answer.
ROC curve of Hollemans nomogram
Nomogram based on 4 variables independently associated with success of catheter drainage: Male sex, multiple organ failure, increasing percentage of pancreatic necrosis and heterogeneity of the collection . Points are awarded to a factor if it is associated with a reduced success chance of catheter drainage. Favorable scores for all factors (ie, 0 points), result in a 91% success chance of primary catheter drainage. Similarly, unfavorable scores (maximum of 40 points) result in a 2% success chance of primary catheter drainage.
Measured: up to 4 months
Secondary outcomes (1)
Potential Predictors of catheter drainage failure
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: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start1 Mar 2018
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234166
- Sponsor's protocol ID
- RC17_0246
- Acronym
- PANIC
- Status last verified
- Apr 2022
- First submitted
- 26 Jul 2017
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Garret C, Douillard M, David A, Pere M, Queneherve L, Legros L, Archambeaud I, Douane F, Lerhun M, Regenet N, Gournay J, Coron E, Frampas E, Reignier J. Infected pancreatic necrosis complicating severe acute pancreatitis in critically ill patients: predicting catheter drainage failure and need for necrosectomy. Ann Intensive Care. 2022 Aug 2;12(1):71. doi: 10.1186/s13613-022-01039-z.
PubMed 35916981
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Necrotizing Pancreatitis and Infected Pancreatic Necrosis: Can we Predict Primary Drainage Failure?
- ClinicalTrials.gov ID
- NCT03234166
- Acronym / sponsor ID
- PANIC / RC17_0246
- Conditions
- Acute Necrotizing Pancreatitis
- Keywords
- Acute necrotizing pancreatitis Acute pancreatitis Pancreas disease Sepsis Infection Drainage Catheters Antibiotics Multiresistant organism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 31 Jul 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.
Acute necrotizing pancreatitis is a frequent and potentially lethal disease, especially in case of infected pancreatic necrosis (IPN). IPN usually occurs after the first week of evolution. The step up approach is now widely recommended for the management of IPN. In fact, in case of suspicion of IPN, a drainage percutaneous or transgastric is recommended at first, supported by probabilist antibiotherapy. 1/3 of patients won't require any other interventions. For 2/3 of patients, an additional necrosectomy is necessary. Necrosectomy was formally realized by open laparotomy. Since de last decade, mini-invasive technics have emerged: transgastric necrosectomy, video-assist retroperitoneal debridement. laparoscopy and permitted a decreased of morbidity and mortality. Recently, Hollemans et al. developed a nomogram based on 4 variables (sex, multi-organ failure, % of necrosis and collections heterogeneity) which are negative predictors for success of catheter drainage in IPN with an receiver operating characteristic (ROC) curve at 0.76. The aim of this study is to validate on a large retrospective cohort Hollemans nomogram in predicting catheter drainage success. Secondary aims are to evaluate possible others predictors for success of catheter drainage in IPN and to evaluate the impact of antibiotherapy on microbiological results and on the need for an additional necrosectomy regarding its type and duration, as well as the emergence of multiresistance organism.
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, Rennes, Angers and Brest University Hospital from January 1, 2012, to december 31, 2017. For enrolled patients, general clinical characteristics were collected. Patients were categorized into two groups according to success of catheter drainage or failure of catheter drainage, and the differences of these characteristics between two groups were evaluated. The Hollemans nomogram is evaluate and potential risk factors will be collected and studied by using multiple logistic regression analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major patient, hospitalized with a diagnosis of acute necrotizing pancreatitis between 2012 and 2016, whatever the etiology, complicated by a necrosis infection infection (either proven or strongly suspected) requiring the initiation of antibiotic therapy and a drainage gesture of this CCM.
Key inclusion criteria (10 listed)
- Adult patients (age >18 years) with acute necrotizing pancreatitis
- IPN proven or highly suspected (proven=positive cultures on pancreatic collections or gas on CT, highly suspected= sepsis without any others infection)
- The need for a catheter drainage
- patients under 18 years
- lack of radiologic evidence to diagnose acute necrotizing pancreatitis,
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Non interventional studyOnly data will be taken of patient's file. | Other | – |
Primary outcome
ROC curve of Hollemans nomogram
Time frame: up to 4 months
Nomogram based on 4 variables independently associated with success of catheter drainage: Male sex, multiple organ failure, increasing percentage of pancreatic necrosis and heterogeneity of the collection . Points are awarded to a factor if it is associated with a reduced success chance of catheter drainage. Favorable scores for all factors (ie, 0 points), result in a 91% success chance of primary catheter drainage. Similarly, unfavorable scores (maximum of 40 points) result in a 2% success chance of primary catheter drainage.
1 secondary outcome
Potential Predictors of catheter drainage failure
Time frame: up to 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 28 Apr 2022.
- Derived from this study: PubMed 35916981Garret C, Douillard M, David A, Pere M, Queneherve L, Legros L, Archambeaud I, Douane F, Lerhun M, Regenet N, Gournay J, Coron E, Frampas E, Reignier J. Infected pancreatic necrosis complicating severe acute pancreatitis in critically ill patients: predicting catheter drainage failure and need for necrosectomy. Ann Intensive Care. 2022 Aug 2;12(1):71. doi: 10.1186/s13613-022-01039-z.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites 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, run by Nantes University Hospital at 4 sites 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 10 inclusion and 0 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 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
ROC curve of Hollemans nomogram (time frame: up to 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 NCT03234166, 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 28 Apr 2022.