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

- Other: Non interventional study
Only data will be taken of patient's file.
- 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.
- 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

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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 |
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

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
Contact: Charlotte GARRET | +33240084737 | charlotte.garret@chu-nantes.fr |
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Acute necrotizing pancreatitis Acute pancreatitis Pancreas disease Sepsis Infection Drainage Catheters Antibiotics Multiresistant organism |
Pancreatitis Pancreatitis, Acute Necrotizing Necrosis |
Pancreatic Diseases Digestive System Diseases Pathologic Processes |