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

Sandra van Brunschot*, Janneke van Grinsven, Rogier P. Voermans, Olaf J. Bakker, Marc G. H. Besselink, Marja A. Boermeester, Thomas L. Bollen, Koop Bosscha, Stefan A. Bouwense, Marco J. Bruno, Vincent C. Cappendijk, Esther C. Consten, Cornelis H. Dejong, Marcel G. W. Dijkgraaf, Casper H. van Eijck, G. Willemien Erkelens, Harry van Goor, Mohammed Hadithi, Jan-Willem Haveman, Hendrik HofkerJeroen J. M. Jansen, Johan S. Lameris, Krijn P. van Lienden, Eric R. Manusama, Maarten A. Meijssen, Chris J. Mulder, Vincent B. Nieuwenhuis, Jan-Werner Poley, Rogier J. de Ridder, Camiel Rosman, Alexander F. Schaapherder, Joris J. Scheepers, Erik J. Schoon, Tom Seerden, B. W. Marcel Spanier, Jan Willem A. Straathof, Robin Timmer, Niels G. Venneman, Frank P. Vleggaar, Ben J. Witteman, Hein G. Gooszen, Hjalmar C. van Santvoort, Paul Fockens, Dutch Pancreatitis Study Grp

*Bijbehorende auteur voor dit werk

    OnderzoeksoutputAcademicpeer review

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    Samenvatting

    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.

    Originele taal-2English
    Artikelnummer161
    Aantal pagina's13
    TijdschriftBmc gastroenterology
    Volume13
    DOI's
    StatusPublished - 25-nov-2013

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