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©The Author(s) 2021.
World J Gastrointest Surg. Nov 27, 2021; 13(11): 1372-1389
Published online Nov 27, 2021. doi: 10.4240/wjgs.v13.i11.1372
Published online Nov 27, 2021. doi: 10.4240/wjgs.v13.i11.1372
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 |
- Citation: Zheng Z, Lu JD, Ding YX, Guo YL, Mei WT, Qu YX, Cao F, Li F. Comparison of safety, efficacy, and long-term follow-up between “one-step” and “step-up” approaches for infected pancreatic necrosis. World J Gastrointest Surg 2021; 13(11): 1372-1389
- URL: https://www.wjgnet.com/1948-9366/full/v13/i11/1372.htm
- DOI: https://dx.doi.org/10.4240/wjgs.v13.i11.1372