Abstract
BackgroundInfected necrotising pancreatitis is a potentially lethal disease that nearly always requires intervention. Traditionally, primary open necrosectomy has been the treatment of choice. In recent years, the surgical step-up approach, consisting of percutaneous catheter drainage followed, if necessary, by (minimally invasive) surgical necrosectomy has become the standard of care. A promising minimally invasive alternative is the endoscopic transluminal step-up approach. This approach consists of endoscopic transluminal drainage followed, if necessary, by endoscopic transluminal necrosectomy. We hypothesise that the less invasive endoscopic step-up approach is superior to the surgical step-up approach in terms of clinical and economic outcomes.Methods/DesignThe TENSION trial is a randomised controlled, parallel-group superiority multicenter trial. Patients with (suspected) infected necrotising pancreatitis with an indication for intervention and in whom both treatment modalities are deemed possible, will be randomised to either an endoscopic transluminal or a surgical step-up approach. During a 4 year study period, 98 patients will be enrolled from 24 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite of death and major complications within 6 months following randomisation. Secondary endpoints include complications such as pancreaticocutaneous fistula, exocrine or endocrine pancreatic insufficiency, need for additional radiological, endoscopic or surgical intervention, the need for necrosectomy after drainage, the number of (re-)interventions, quality of life, and total direct and indirect costs.DiscussionThe TENSION trial will answer the question whether an endoscopic step-up approach reduces the combined primary endpoint of death and major complications, as well as hospital stay and related costs compared with a surgical step-up approach in patients with infected necrotising pancreatitis.
Highlights
Infected necrotising pancreatitis is a potentially lethal disease that nearly always requires intervention
The TENSION trial will answer the question whether an endoscopic step-up approach reduces the combined primary endpoint of death and major complications, as well as hospital stay and related costs compared with a surgical step-up approach in patients with infected necrotising pancreatitis
Study objectives The primary aim of this study is to investigate whether an endoscopic step-up approach will reduce the combined primary endpoint of death and major complications, as well as the secondary endpoints, hospital stay and costs, as compared to a surgical step-up approach in patients with infected necrotising pancreatitis
Summary
The TENSION trial is designed to answer the question whether an endoscopic step-up approach will lead to a reduction of death and major complications compared to a surgical step-up approach in patients with (suspected) infected necrosis. In the PANTER trial, the surgical step-up approach reduced the combined death and major complication rate from 69% to 40% [2]. Endoscopic drainage and necrosectomy are advanced interventions that require the expertise from an interventional endoscopist, and the dedicated involvement of interventional radiologists and pancreatic surgeons to manage potential complications. For this reason the endoscopic interventions in the TENSION trial will only be performed in expert centers with multidisciplinary expertise
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