Acute Necrotizing Pancreatitis and Infected Pancreatic Necrosis

Acute Necrotizing Pancreatitis Clinical Trial

— PANIC  

Official title:

Acute Necrotizing Pancreatitis and Infected Pancreatic Necrosis: Can we Predict Primary Drainage Failure?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03234166
• Other study ID #: RC17_0246
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: April 2022
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Necrotizing Pancreatitis
• Necrosis
• Pancreatitis
• Pancreatitis, Acute Necrotizing

Intervention

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

Locations

Country	Name	City	State
France	Angers University Hospital	Angers
France	Brest University Hospital	Brest
France	Nantes University Hospital	Nantes
France	Rennes University Hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 4 months
Secondary	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	up to 4 months