Table 1. Definitions of Outcomes.
| Outcome | Definition |
|---|---|
| New onset | Not present any time in 24 h before first intervention |
| Major complications | Single- or multiple-organ failure (eg, failure of ≥2 organ systems), bile leakage or gastroenterostomy leakage, or postpancreatectomy hemorrhage requiring intervention |
| Organ failure | |
| Pulmonary | Pao2 <60 mm Hg despite FiO2 of 0.3 or need for mechanical ventilation |
| Circulatory | Systolic blood pressure <90 mm Hg despite adequate fluid resuscitation or need for inotropic support |
| Renal | Creatinine level >2.0 mg/dL after rehydration or need for hemofiltration or hemodialysis |
| Postoperative pancreatic fistula | Amylase in drain fluid on or after postoperative day 3 of ≥3 times the upper level of normal serum amylase |
| Grade A | Requiring no change in postoperative management; hospital stay not prolonged |
| Grade B | Requiring change in postoperative management (ie, catheter drainage, discharge with intraoperatively placed drains in situ, or no relaparotomy); length of hospital stay might be prolonged |
| Grade C | Requiring relaparotomy and/or admission to ICU and/or pancreatic fistula leading to death; length of hospital stay prolonged |
| Severe pancreatic fistula | Requiring additional drainage or discharged with intraoperatively placed drain in place; requiring relaparotomy (ie, with surgical drainage or additional pancreatic resection) |
| Postoperative bile leakage | Bilirubin in drain fluid on or after postoperative day 3 of ≥3 times the upper level of normal serum bilirubin (adapted from Koch et al) |
| Delayed gastric emptying | Adapted from Wente et al |
| Grade A | Nasogastric tube on postoperative days 4-7 or need for replacement of tube after postoperative day 3; oral intake between days 7 and 14 |
| Grade B | Nasogastric tube on postoperative days 8-14 or need for replacement of tube after postoperative day 7; oral intake between days 14 and 21 |
| Grade C | Nasogastric tube after postoperative day 14 or need for replacement of tube after postoperative day 14; oral intake after day 14 |
| Gastroenteral leakage | Observed on abdominal imaging or during relaparotomy or secretion of fecal material from percutaneous drain or through surgical wound |
| Acute pancreatitis | Combination of abdominal pain, 3-fold increased amylase and lipase levels, or as observed on radiologic imaging |
| New-onset diabetes | Need for insulin or oral diabetic drugs within 3 mo after discharge; not present before pancreatoduodenectomy |
| Exocrine pancreatic insufficiency | Need for oral pancreatic enzyme supplementation within 3 mo after discharge; not present before pancreatoduodenectomy |
Abbreviations: Fio2, fraction of inspired oxygen; ICU, intensive care unit; Pao2, partial pressure of arterial oxygen.
SI conversion factor: To convert creatinine to micromoles per liter, multiply by 88.4.