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Acute Necrotizing Pancreatitis and Infected Pancreatic Necrosis (PANIC)

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ClinicalTrials.gov Identifier: NCT03234166
Recruitment Status : Unknown
Verified July 2017 by Nantes University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : July 31, 2017
Last Update Posted : July 31, 2017
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment
Acute Necrotizing Pancreatitis Other: Non interventional study

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
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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Acute Necrotizing Pancreatitis and Infected Pancreatic Necrosis: Can we Predict Primary Drainage Failure?
Estimated Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Groups and Cohorts
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Intervention Details:
  • Other: Non interventional study
    Only data will be taken of patient's file.

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Potential Predictors of catheter drainage failure [ Time Frame: up to 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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,
  • no suspicion or confirmation of IPN
  • no need for a drainage
  • unable to receive a drainage
  • pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03234166


Contacts
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Contact: Charlotte GARRET +33240084737 charlotte.garret@chu-nantes.fr

Locations
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France
Angers University Hospital
Angers, France, 49100
Contact: Elodie METIVIER-CESBRON, Dr       ElMetivierCesbron@chu-angers.fr   
Principal Investigator: Elodie METIVIER-CESBRON, Dr         
Brest University Hospital
Brest, France, 29200
Contact: Ruben ARNASHELLUM, Dr       ruben.arnachellum@chu-brest.fr   
Principal Investigator: Ruben ARNASHELLUM, Dr         
Nantes University Hospital
Nantes, France, 44093
Contact: Garret Charlotte    +33240084737    charlotte.garret@chu-nantes.fr   
Principal Investigator: Garret Charlotte         
Rennes University Hospital
Rennes, France, 35033
Contact: Ludivine LEGROS, Dr       ludivine.legros@chu-rennes.fr   
Principal Investigator: Ludivine LEGROS, Dr         
Sponsors and Collaborators
Nantes University Hospital
More Information
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03234166    
Other Study ID Numbers: RC17_0246
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
Acute necrotizing pancreatitis Acute pancreatitis Pancreas disease Sepsis Infection Drainage Catheters Antibiotics Multiresistant organism
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Acute Necrotizing
Necrosis
 Pancreatic Diseases
Digestive System Diseases
Pathologic Processes