Table 1 The primary and secondary endpoints of the WONDER-01 trial
Primary endpoint | Secondary endpoints |
|---|---|
Time from randomisation to clinical successa | Incidence of procedure-related adverse events graded by the AGREE classification [25] as well as the ASGE lexicon guideline [26] |
Clinical success is defined as (1) a decrease in a WON size to 3 cm or less and (2) an improvement of at least two out of the three inflammatory markers (i.e. body temperature, white blood cell count, and C-reactive protein) | Mortality from any cause |
Technical success rate of the initial EUS-guided drainage | |
Incidence of a biliary stricture and gastrointestinal obstruction | |
Number of interventions | |
Total procedure time | |
Time requiring endoscopic and/or percutaneous drainage | |
Length of hospitalisation | |
Length of ICU stay | |
Duration of antibiotics administration | |
Total costs of interventions and hospitalisation | |
Incidence of WON recurrence | |
Time from clinical success to WON recurrence | |
Incidence of a pancreatic pseudocyst | |
Incidence of new-onset diabetes | |
Incidence of clinical symptoms associated with pancreatic exocrine insufficiency | |
Incidence of pancreatic cancer | |
Incidence of sarcopenia | |
Changes in the morphology and volume of the pancreas |