Clinical Trials Directory

Trials / Completed

CompletedNCT03234166

Acute Necrotizing Pancreatitis and Infected Pancreatic Necrosis

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

Status
Completed
Phase
Study type
Observational
Enrollment
72 (actual)
Sponsor
Nantes University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERNon interventional studyOnly data will be taken of patient's file.

Timeline

Start date
2018-03-01
Primary completion
2019-03-01
Completion
2019-03-01
First posted
2017-07-31
Last updated
2022-04-28

Locations

4 sites across 1 country: France

Source: ClinicalTrials.gov record NCT03234166. Inclusion in this directory is not an endorsement.