Clinical trial NCT03234166: Acute Necrotizing Pancreatitis and Infected Pancreatic Necrosis
Official title: Acute Necrotizing Pancreatitis and Infected Pancreatic Necrosis: Can we Predict Primary Drainage Failure?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Necrotizing Pancreatitis
Keywords: Acute necrotizing pancreatitis Acute pancreatitis Pancreas disease Sepsis Infection Drainage Catheters Antibiotics Multiresistant organism
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2017-07-31
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: ROC curve of Hollemans nomogram
timeFrame: up to 4 months
Secondary outcomes:
measure: Potential Predictors of catheter drainage failure
timeFrame: up to 4 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Brest
country: France
facility: Brest University Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Rennes
country: France
facility: Rennes University Hospital
Study officials:
References:
citation: 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.