Transluminal endoscopic step-up approach versus minimally invasive surgical step-up approach in patients with infected necrotising pancreatitis (TENSION trial): design and rationale of a randomised controlled multicenter trial [ISRCTN09186711]
Open Access
- 25 November 2013
- journal article
- research article
- Published by Springer Science and Business Media LLC in BMC Gastroenterology
- Vol. 13 (1), 161
- https://doi.org/10.1186/1471-230x-13-161
Abstract
Infected 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. The 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. 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.Keywords
This publication has 31 references indexed in Scilit:
- A Conservative and Minimally Invasive Approach to Necrotizing Pancreatitis Improves OutcomeGastroenterology, 2011
- Endoscopic necrosectomy of pancreatic necrosis: a systematic reviewSurgical Endoscopy, 2011
- CDC/NHSN surveillance definition of health care–associated infection and criteria for specific types of infections in the acute care settingAmerican Journal of Infection Control, 2008
- Debridement and Closed Packing for Sterile or Infected Necrotizing PancreatitisAnnals of Surgery, 2008
- AGA Institute Medical Position Statement on Acute PancreatitisGastroenterology, 2007
- AGA Institute Technical Review on Acute PancreatitisGastroenterology, 2007
- Videoscopic assisted retroperitoneal debridement in infected necrotizing pancreatitisHPB, 2007
- A technique for laparoscopic-assisted percutaneous drainage of infected pancreatic necrosis and pancreatic abscessSurgical Endoscopy, 2001
- Labor and Health Status in Economic Evaluation of Health Care: The Health and Labor QuestionnaireInternational Journal of Technology Assessment in Health Care, 1996
- The MOS 36-ltem Short-Form Health Survey (SF-36)Medical Care, 1992