Endoscopic transluminal step-up approach versus surgical step-up approach in patients with infected necrotizing pancreatitis (TENSION): Design and rationale of a randomized controlled multicenter trial

Abstract

s / Pancreatology 12 (2012) 502–597 575 showed that endoscopic necrosectomy significantly reduced the proinflammatory response as well as complications and death compared to surgical necrosectomy. These preliminary outcomes require confirmation in a larger trial. We describe the design and rationale of a nationwide study called TENSION: “Endoscopic transluminal step-up approach versus surgical step-up approach in patients with infected necrotizing pancreatitis” (Trial registration: ISRCTN09186711). Methods: The TENSION trial is a randomized controlled parallel-group, superiority multicenter trial. Patients with infected necrotizing pancreatitis will be randomized to an endoscopic or surgical step-up approach. The endoscopic step-up approach consists of endoscopic transluminal drainage followed, if necessary, by endoscopic transluminal necrosectomy. The surgical step-up approach consists of percutaneous catheter drainage, if necessary, followed by video-assisted retroperitoneal debridement (VARD). The primary endpoint is a composite of major complications (i.e., new onset organ failure, bleeding requiring intervention, perforation of a visceral organ requiring intervention, enterocutaneous fistula requiring intervention and incisional hernia) or death within 6 months following randomization. Secondary endpoints include other complications such as pancreatic fistula, pancreatic insufficiency, length of intensive careand hospital stay, quality of life, and costs. 98 patients will be enrolled in 25 hospitals of the Dutch Pancreatitis Study Group in a 3-year period. Conclusion: The TENSION trial is designed to evaluate if an endoscopic step-up approach is superior to a surgical step-up approach in terms of clinical outcomes and cost-effectiveness in patients with infected necrotizing pancreatitis.