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Table 3 Inclusion and exclusion criteria: definitions

From: Transluminal endoscopic step-up approach versus minimally invasive surgical step-up approach in patients with infected necrotising pancreatitis (TENSION trial): design and rationale of a randomised controlled multicenter trial [ISRCTN09186711]

Event Definition
Pancreatic necrosis Diffuse or focal area(s) of non-enhancing pancreatic parenchyma as detected on contrast enhanced CT (CECT)
Extrapancreatic necrosis Persistent peripancreatic fluid collections on CECT in the absence of pancreatic parenchymal non-enhancement
(Suspected) infected necrosis • Infected necrosis is defined as a positive culture of pancreatic necrosis or extrapancreatic necrosis obtained by fine-needle aspiration (FNA) or the presence of gas in the fluid collection on CECT.
• Suspected infected necrosis is defined as persistent sepsis or progressive clinical deterioration despite maximal support on the intensive care unit (ICU) in case of pancreatic necrosis or extrapancreatic necrosis, without documentation of infected necrosis and without other causes for infection
Previous intervention Previous exploratory laparotomy for suspected abdominal compartment syndrome, bleeding or suspected bowel perforation is only allowed if the omental bursa was not opened
MODS The Multiple Organ Dysfunction Score (MODS) ranges from 0 to 24, with higher scores indicating more severe organ dysfunction
SOFA Scores on the Sequential Organ Failure Assessment (SOFA) scale range from 0 to 24, with higher scores indicating more severe organ dysfunction