Comparison of safety, efficacy, and long-term follow-up between “one-step” and “step-up” approaches for infected pancreatic necrosis

Table 1 The definitions of primary endpoints and secondary endpoints

Endpoints	Definition
Primary endpoints
Composite endpoint consisting of mortality and severe complications (Clavien-Dindo ≥ IIIa)	There are five grades of Clavien-Dindo Classification: Grade I, any complication that deviates from the natural course after surgery; Grade II, medications other than those permitted for Grade I complications are required; Grade III, surgical, endoscopic, and radiotherapy are required, including Grade IIIa (no general anesthesia is required) and IIIb (need for general anesthesia); Grade IV, life-threatening complication, including Grade IVa (single organ dysfunction) and IVb (multi-organ dysfunction) that require intermittent monitoring or ICU treatment; Grade V, death
Secondary endpoints
New-onset organ failure	New-onset failure of one or more organs in the 24 h prior to the first intervention
Pulmonary failure	Partial pressure of oxygen (PO2) < 60 mmHg with or without partial pressure of carbon dioxide (PCO2) > 50 mmHg, or need for mechanical ventilation
Circulatory failure	Blood pressure < 90/60 mmHg, or need for inotropic catecholamine to maintain blood pressure
Renal failure	The level of creatinine (Cr) > 177 μmoL/L, or need for hemofiltration or hemodialysis
Postoperative intra-abdominal bleeding	Need for operation, radiological, or endoscopic intervention
Pancreatic fistula	Drainage fluid amylase level more than 3 times that of serum amylase
Enterocutaneous fistula	Intestinal contents, including intestinal fluids, food residues, and feces, break through the intestinal wall (small bowel or large bowel) and leak into the abdominal cavity or outside the body. It can also be confirmed by radiology or surgery
Viscera perforation	Need for operation, radiological, or endoscopic intervention
Endocrine insufficiency	Oral hypoglycemic drugs or insulin therapy for at least 6 mo, with no need to take these drugs before the onset of AP
Pancreatic enzyme	Clinical symptoms were improved by oral pancreatic enzyme use for more than 6 mo, with no need to take this drug before the onset of AP
Recurrent pancreatitis	A history of two or more episodes with and interval of at least 3 mo
Chronic pancreatitis	Patients experience abdominal pain, weight loss, diabetes, and fatty diarrhea. The condition is also confirmed by radiological and laboratory examinations. The symptoms did not occur before the onset of AP
Incisional hernia	Six months after discharge, the full-thickness abdominal wall is discontinuous and abdominal contents bulge, with or without obstruction
Pancreatic portal hypertension	AP causes splenic vein thrombosis, which causes obstruction of splenic venous return

AP: Acute pancreatitis; ICU: Intensive care unit.