Pancreatitis, very early compared with normal start of enteral feeding (PYTHON trial): design and rationale of a randomised controlled multicenter ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2011-12

AUTHORS

Olaf J Bakker, Hjalmar C van Santvoort, Sandra van Brunschot, Usama Ahmed Ali, Marc G Besselink, Marja A Boermeester, Thomas L Bollen, Koop Bosscha, Menno A Brink, Cornelis H Dejong, Erwin J van Geenen, Harry van Goor, Joos Heisterkamp, Alexander P Houdijk, Jeroen M Jansen, Thom M Karsten, Eric R Manusama, Vincent B Nieuwenhuijs, Bert van Ramshorst, Alexander F Schaapherder, George P van der Schelling, Marcel BM Spanier, Adriaan Tan, Juda Vecht, Bas L Weusten, Ben J Witteman, Louis M Akkermans, Hein G Gooszen, the Dutch Pancreatitis Study Group

ABSTRACT

BACKGROUND: In predicted severe acute pancreatitis, infections have a negative effect on clinical outcome. A start of enteral nutrition (EN) within 24 hours of onset may reduce the number of infections as compared to the current practice of starting an oral diet and EN if necessary at 3-4 days after admission. METHODS/DESIGN: The PYTHON trial is a randomised controlled, parallel-group, superiority multicenter trial. Patients with predicted severe acute pancreatitis (Imrie-score ≥ 3 or APACHE-II score ≥ 8 or CRP > 150 mg/L) will be randomised to EN within 24 hours or an oral diet and EN if necessary, after 72 hours after hospital admission.During a 3-year period, 208 patients will be enrolled from 20 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite of mortality or infections (bacteraemia, infected pancreatic or peripancreatic necrosis, pneumonia) during hospital stay or within 6 months following randomisation. Secondary endpoints include other major morbidity (e.g. new onset organ failure, need for intervention), intolerance of enteral feeding and total costs from a societal perspective. DISCUSSION: The PYTHON trial is designed to show that a very early (< 24 h) start of EN reduces the combined endpoint of mortality or infections as compared to the current practice of an oral diet and EN if necessary at around 72 hours after admission for predicted severe acute pancreatitis. TRIAL REGISTRATION: ISRCTN: ISRCTN18170985. More... »

PAGES

73

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/1745-6215-12-73

DOI

http://dx.doi.org/10.1186/1745-6215-12-73

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1037890752

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/21392395


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