Abstract

Doc number: 161

Abstract

Background: 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.

Methods/Design: 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.

Discussion: 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.

Details

Title
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]
Author
van Brunschot, Sandra; van Grinsven, Janneke; Voermans, Rogier P; Bakker, Olaf J; Besselink, Marc GH; Boermeester, Marja A; Bollen, Thomas L; Bosscha, Koop; Bouwense, Stefan A; Bruno, Marco J; Cappendijk, Vincent C; Consten, Esther C; Dejong, Cornelis H; Dijkgraaf, Marcel GW; van Eijck, Casper H; Erkelens, G Willemien; van Goor, Harry; Hadithi, Mohammed; Haveman, Jan-Willem; Hofker, Sijbrand H; Jansen, Jeroen JM; Laméris, Johan S; van Lienden, Krijn P; Manusama, Eric R; Meijssen, Maarten A; Mulder, Chris J; Nieuwenhuis, Vincent B; Poley, Jan-Werner; de Ridder, Rogier J; Rosman, Camiel; Schaapherder, Alexander F; Scheepers, Joris J; Schoon, Erik J; Seerden, Tom; Spanier, BW Marcel; Straathof, Jan Willem A; Timmer, Robin; Venneman, Niels G; Vleggaar, Frank P; Witteman, Ben J; Gooszen, Hein G; van Santvoort, Hjalmar C; Fockens, Paul
Pages
161
Publication year
2013
Publication date
2013
Publisher
BioMed Central
e-ISSN
1471230X
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
1465437001
Copyright
© 2013 van Brunschot et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.