Table 2 Secondary endpoint: definitions

Pancreaticocutaneous fistula

Pancreaticocutaneous fistula is defined as output, through a percutaneous drain, drainage canal after removal of drains, or from a surgical wound, of any measurable volume of fluid with an amylase content > 3 times the serum amylase level

Pancreatic insufficiency

• Exocrine insufficiency is defined as an abnormal fecal elastase test or the need for oral pancreatic-enzyme supplementation to treat clinical symptoms of steatorrhea (not present before onset pancreatitis)

• Endocrine insufficiency is defined as insulin or oral antidiabetic drugs required (not present before onset pancreatitis)

Wound infection [9]

Wound infection is defined as a superficial incisional surgical site infection (SSI) and must meet the following criterion:

Infection occurs within 30 days after the operative procedure and involves only skin and subcutaneous tissue of the incision and the patient has at least 1 of the following:

­purulent drainage from the superficial/deep incision but not from the organ/space component of the surgical site

­organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision

­at least 1 of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat

­the superficial incision is deliberately opened by surgeon and is culture positive or not cultured. A culture-negative finding does not meet this criterion

­an abscess or other evidence of infection involving the deep incision is found on direct examination, during reoperation, or by histopathologic or radiologic examination

­diagnosis of superficial/deep incisional SSI by the surgeon or attending physician