Minimally invasive 'step-up approach' versus maximal necrosectomy in patients with acute necrotising pancreatitis (PANTER trial): design and rationale of a randomised controlled multicenter trial [ISRCTN13975868]

88 patients with (suspected) infected necrotizing pancreatitis will be randomly allocated to either group A) minimally invasive 'step-up approach' starting with drainage followed, if necessary, by videoscopic assisted retroperitoneal debridement (VARD) or group B) maximal necrosectomy by laparotomy. Both procedures are followed by CPL. Patients will be recruited from 20 hospitals, including all Dutch university medical centres, over a 3-year period. The primary endpoint is the proportion of patients suffering from postoperative major morbidity and mortality. Secondary endpoints are complications, new onset sepsis, length of hospital and intensive care stay, quality of life and total (direct and indirect) costs. To demonstrate that the 'step-up approach' can reduce the major morbidity and mortality rate from 45 to 16%, with 80% power at 5% alpha, a total sample size of 88 patients was calculated.The PANTER-study is a randomised controlled trial that will provide evidence on the merits of a minimally invasive 'step-up approach' in patients with (suspected) infected necrotizing pancreatitis.The initial treatment of acute necrotizing pancreatitis is conservative [1-4]. Once (peri-)pancreatic necrosis becomes infected mortality increases steeply [3,4]. Intervention is indicated when infection of (peri-)pancreatic necrosis is proven by fine needle aspiration (FNA), when (peri-)pancreatic air collections in the necrotic cavity are depicted on computer tomography (CT) scan or when sepsis persists despite maximal support on the intensive care unit. Surgical intervention within the first 14 days after the onset of symptoms should be averted because of notoriously poor outcome in this phase of disease [4,5]. Organ failure needing intensive care treatment during the first two weeks should be interpreted as a complication of a systemic inflammatory response syndrome (SIRS).There is no consensus in the literature on the optimal surgical strategy in infected necrotizing pancreatit