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Table 1 Primary endpoint: 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
Organ failure Organ failure is defined as:
• Cardiovascular: systolic blood pressure < 90 mmHg despite adequate fluid resuscitation or need for vasopressor support
• Pulmonary: PaO2 < 60 mmHg despite FiO2 30%, or the need for mechanical ventilation;
• Renal: serum creatinine > 177 mmol/L after rehydration or need for hemofiltration or hemodialysis;
Definitions are adapted from the Atlanta classification and the same as previously used in the PANTER trial [2]
New onset organ failure Organ failure occurring after randomisation and not present 24 hours before randomisation
Multiple organ failure Failure of 2 or more organ systems on the same day
Enterocutaneous fistula Enterocutaneous fistula is defined as secretion of fecal material from a percutaneous drain, drainage canal after removal of drains, or from a surgical wound, either from small or large bowel; confirmed by imaging or during surgery [2]
Incisional hernia Incisional hernia is defined as a full-thickness discontinuity of the abdominal wall and bulging of abdominal contents, with or without obstruction [2]